The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Laceration And Instrument Trays.
Device ID | K873290 |
510k Number | K873290 |
Device Name: | LACERATION AND INSTRUMENT TRAYS |
Classification | Tray, Surgical |
Applicant | ADVANTAGE MEDICAL SYSTEMS, INC. 905 SHEEHY DR. Horsham, PA 19044 |
Contact | Joel A Marcus |
Correspondent | Joel A Marcus ADVANTAGE MEDICAL SYSTEMS, INC. 905 SHEEHY DR. Horsham, PA 19044 |
Product Code | LRP |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-17 |
Decision Date | 1987-09-24 |