The following data is part of a premarket notification filed by Eare Consulting Service with the FDA for Accessories Foe Orthopedic Surgical Procedures.
| Device ID | K950592 |
| 510k Number | K950592 |
| Device Name: | ACCESSORIES FOE ORTHOPEDIC SURGICAL PROCEDURES |
| Classification | Arthroscope |
| Applicant | EARE CONSULTING SERVICE P.O. BOX 1309 Eilat, IL 88112 |
| Contact | Emanuel A Rosen |
| Correspondent | Emanuel A Rosen EARE CONSULTING SERVICE P.O. BOX 1309 Eilat, IL 88112 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-09 |
| Decision Date | 1995-06-01 |