The following data is part of a premarket notification filed by Arthropedics, Inc. with the FDA for Standard Knife, Disposable #tm-1610.
Device ID | K873712 |
510k Number | K873712 |
Device Name: | STANDARD KNIFE, DISPOSABLE #TM-1610 |
Classification | Knife, Orthopedic |
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 | HTS |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-15 |
Decision Date | 1987-10-15 |