(29 days)
Not Found
Orthopedic Kit or Tray
I am sorry, but the provided text from the 510(k) summary (Attachment 1) does not contain information about acceptance criteria, device performance, clinical studies, sample sizes, ground truth, or expert involvement.
The document primarily focuses on:
- Submitter Information: Name and address of National Healthcare Manufacturing Corp. and their general manager.
- 510(k) Summary Preparer: Information about the consultant preparing the summary.
- Date Prepared: April 1, 1997.
- Device Name/Classification: Identifying the device as an "Orthopedic Pack, Tray, or Kit" and noting the absence of a specific classification name.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text.
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Image /page/0/Picture/0 description: The image contains three lowercase letters: 'm', 'd', and 'i'. The letters are written in a bold, outlined font, giving them a distinct appearance. The letters are arranged horizontally, with 'm' on the left, 'd' in the center, and 'i' on the right.
Attachment 1 510(k) Summary
MAY - 8 1997
K9713/7
National Healthcare Manufacturing Corp. Orthopedic Kit or Tray
Submitter Information:
Alice Gibson General Manager National Healthcare Manufacturing Corp. 251 Sulteaux Crescent Winnipeg, Manitoba R3J 3C7 Canada
510(k) Summary Prepared by:
Carolann Kotula Official Correspondent for NHMC c/o mdi Consultants, Inc. 55 Northern Boulevard Great Neck, NY 11021
| Phone: | (516) 482-9001 |
|---|---|
| Fax: | (516) 482-0186 |
Date 510(k) Summary Prepared:
April 1, 1997
Name/Classification of the Device:
Classification Name:
A classification name could not be located for these devices.
Common Name:
Orthopedic Pack, Tray, or Kit
Page - 1
Consulting since 1978
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.