The following data is part of a premarket notification filed by E.m. Adams with the FDA for Sterile Instrument Trays-various.
Device ID | K843723 |
510k Number | K843723 |
Device Name: | STERILE INSTRUMENT TRAYS-VARIOUS |
Classification | Tray, Surgical, Instrument |
Applicant | E.M. ADAMS 121 WEST ST. Medfield, MA 02052 |
Contact | Richard K Donahue |
Correspondent | Richard K Donahue E.M. ADAMS 121 WEST ST. Medfield, MA 02052 |
Product Code | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-24 |
Decision Date | 1984-10-23 |