The following data is part of a premarket notification filed by Mumtaz I. Malik with the FDA for Sterile Laceration Tray.
Device ID | K890071 |
510k Number | K890071 |
Device Name: | STERILE LACERATION TRAY |
Classification | Tray, Surgical |
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 | LRP |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-09 |
Decision Date | 1989-01-24 |