The following data is part of a premarket notification filed by Mumtaz I. Malik with the FDA for Volkman Bone Currette 5, 5-3/4, 6-3/4, 8.
Device ID | K901420 |
510k Number | K901420 |
Device Name: | VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8 |
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 | 1990-03-26 |
Decision Date | 1990-09-28 |