The following data is part of a premarket notification filed by Mumtaz I. Malik with the FDA for General Surgical Instruments (various Types).
Device ID | K884195 |
510k Number | K884195 |
Device Name: | GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES) |
Classification | Forceps, General & Plastic Surgery |
Applicant | MUMTAZ I. MALIK HELM HOUSE 100 DIECKS DRIVE Elizabethtown, KY 42701 |
Contact | Malik, M.d. |
Correspondent | Malik, M.d. MUMTAZ I. MALIK HELM HOUSE 100 DIECKS DRIVE Elizabethtown, KY 42701 |
Product Code | GEN |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-06 |
Decision Date | 1988-10-24 |