The following data is part of a premarket notification filed by Arthropedics, Inc. with the FDA for Video Arthroscope, 1.7mm X 55 Mm.
Device ID | K873387 |
510k Number | K873387 |
Device Name: | VIDEO ARTHROSCOPE, 1.7MM X 55 MM |
Classification | Spatula, Orthopedic |
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 | HXR |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-26 |
Decision Date | 1987-11-25 |