The following data is part of a premarket notification filed by Mumtaz I. Malik with the FDA for Chisel, Bone, Surgical.
Device ID | K901511 |
510k Number | K901511 |
Device Name: | CHISEL, BONE, SURGICAL |
Classification | Manipulator, Plunger-like Joint |
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 | LXM |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-29 |
Decision Date | 1990-09-28 |