The following data is part of a premarket notification filed by Brown Medical Industries with the FDA for Pin Care Kit.
Device ID | K973299 |
510k Number | K973299 |
Device Name: | PIN CARE KIT |
Classification | Gauze/sponge, Internal |
Applicant | BROWN MEDICAL INDUSTRIES 1300 LUNDBERG DRIVE WEST Spirit Lake, IA 51360 -7246 |
Contact | Bob Petrosenko |
Correspondent | Bob Petrosenko BROWN MEDICAL INDUSTRIES 1300 LUNDBERG DRIVE WEST Spirit Lake, IA 51360 -7246 |
Product Code | EFQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-02 |
Decision Date | 1997-11-26 |
Summary: | summary |