The following data is part of a premarket notification filed by Mumtaz I. Malik with the FDA for 4 X 4 Sterile Gauze Sponge Tray.
Device ID | K893902 |
510k Number | K893902 |
Device Name: | 4 X 4 STERILE GAUZE SPONGE TRAY |
Classification | Gauze/sponge, Internal |
Applicant | MUMTAZ I. MALIK HELM HOUSE 100 DIECKS DRIVE Elizabethtown, KY 42701 |
Contact | M. I Malik |
Correspondent | M. I Malik MUMTAZ I. MALIK HELM HOUSE 100 DIECKS DRIVE Elizabethtown, KY 42701 |
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 | 1989-05-30 |
Decision Date | 1989-07-14 |