Who is the manufacturer of CPR DRESSING CHANGE TRAY?

Custom Pack Reliability submitted the Traditional clearance for CPR DRESSING CHANGE TRAY (K960206).

What is the FDA product code for CPR DRESSING CHANGE TRAY?

FRG. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for CPR DRESSING CHANGE TRAY?

510(k) clearance (submission type: Traditional).

CPR DRESSING CHANGE TRAY

K960206 · Custom Pack Reliability · FRG · Apr 12, 1996 · General Hospital

Device Facts

Record ID	K960206
Device Name	CPR DRESSING CHANGE TRAY
Applicant	Custom Pack Reliability
Product Code	FRG · General Hospital
Decision Date	Apr 12, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.