The following data is part of a premarket notification filed by Grand Medical Products with the FDA for Laceration Tray.
Device ID | K963723 |
510k Number | K963723 |
Device Name: | LACERATION TRAY |
Classification | Tray, Surgical |
Applicant | GRAND MEDICAL PRODUCTS 1300 REMINGTON ROAD, SUITE K Schaumburg, IL 60173 |
Contact | Harvey Weiss |
Correspondent | Harvey Weiss GRAND MEDICAL PRODUCTS 1300 REMINGTON ROAD, SUITE K Schaumburg, IL 60173 |
Product Code | LRP |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-16 |
Decision Date | 1996-11-27 |