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510(k) Data Aggregation
K Number
K121604Device Name
ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT
Manufacturer
OBP CORPORATION
Date Cleared
2012-07-27
(56 days)
Product Code
FER
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
OBP CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AnoSPEC Disposable Anoscope with light is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Device Description
AnoSPEC Disposable Anoscope with light
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K Number
K091937Device Name
OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM
Manufacturer
OBP CORPORATION
Date Cleared
2009-09-09
(71 days)
Product Code
HIB
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
OBP CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OBP Office-Spec Disposable Side Speculum is indicated for use on women undergoing a procedure requiring vaginal access and exposure (e.g., for a pelvic exam or Pap smear). The device uses opposing bi-valve plastic blades to separate the vaginal wall and is intended to expose the interior of the vagina and exterior of the cervix. It may be used with or without a removable light source.
Device Description
The OBP Office-Spec Disposable Side Speculum is indicated for use on women undergoing a procedure requiring vaginal access and exposure (e.g., for a pelvic exam or Pap smear). The device uses opposing bi-valve plastic blades to separate the vaginal wall and is intended to expose the interior of the vagina and exterior of the cervix. It may be used with or without a removable light source.
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