The following data is part of a premarket notification filed by Orthoconcept, Inc. with the FDA for Arthroscopy Disp. & Reusable Shaver Blades, Rechar.
Device ID | K896196 |
510k Number | K896196 |
Device Name: | ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR |
Classification | Arthroscope |
Applicant | ORTHOCONCEPT, INC. 8 COLD BRANCH CT Columbia, SC 29223 |
Contact | Jack Defranco |
Correspondent | Jack Defranco ORTHOCONCEPT, INC. 8 COLD BRANCH CT Columbia, SC 29223 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-25 |
Decision Date | 1989-12-01 |