The following data is part of a premarket notification filed by Mumtaz I. Malik with the FDA for Rongeur, Orthopedic Surgical Instruments.
| Device ID | K901289 |
| 510k Number | K901289 |
| Device Name: | RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS |
| Classification | Orthopedic Manual Surgical Instrument |
| 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 | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-20 |
| Decision Date | 1990-09-28 |