The following data is part of a premarket notification filed by Arthropedics, Inc. with the FDA for Sterilization Tray, Tmj Instrument Set.
Device ID | K871924 |
510k Number | K871924 |
Device Name: | STERILIZATION TRAY, TMJ INSTRUMENT SET |
Classification | Tray, Surgical, Instrument |
Applicant | ARTHROPEDICS, INC. 111 LESTER ST. Wallington, NJ 07057 |
Contact | Herbert Schainholz |
Correspondent | Herbert Schainholz ARTHROPEDICS, INC. 111 LESTER ST. Wallington, NJ 07057 |
Product Code | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-18 |
Decision Date | 1987-06-01 |