The following data is part of a premarket notification filed by Arthropedics, Inc. with the FDA for C-o-t Set (cannula, Obturator And Trocar) #tm-1360.
Device ID | K873650 |
510k Number | K873650 |
Device Name: | C-O-T SET (CANNULA, OBTURATOR AND TROCAR) #TM-1360 |
Classification | Arthroscope |
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 | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-10 |
Decision Date | 1987-11-02 |