The following data is part of a premarket notification filed by Arthropedics, Inc. with the FDA for Hook Probe #tm-1376.
Device ID | K873652 |
510k Number | K873652 |
Device Name: | HOOK PROBE #TM-1376 |
Classification | Probe |
Applicant | ARTHROPEDICS, INC. 111 LESTER ST. Wallington, NJ 07057 |
Contact | Jerry Procopio |
Correspondent | Jerry Procopio ARTHROPEDICS, INC. 111 LESTER ST. Wallington, NJ 07057 |
Product Code | HXB |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-10 |
Decision Date | 1987-11-02 |