The following data is part of a premarket notification filed by Arthropedics, Inc. with the FDA for Serrated Grasping Forceps, Right.
Device ID | K873512 |
510k Number | K873512 |
Device Name: | SERRATED GRASPING FORCEPS, RIGHT |
Classification | Forceps |
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 | HTD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-31 |
Decision Date | 1987-11-02 |