The following data is part of a premarket notification filed by Surgical Instruments Service And Savings, Inc. with the FDA for Reprocessed Arthroscopic Shapers.
| Device ID | K012667 |
| 510k Number | K012667 |
| Device Name: | REPROCESSED ARTHROSCOPIC SHAPERS |
| Classification | Arthroscope |
| Applicant | SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. 3636 E COLUMBINE DR. Phoenix, AZ 85032 -5655 |
| Contact | Robert S Mcquate |
| Correspondent | Robert S Mcquate SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. 3636 E COLUMBINE DR. Phoenix, AZ 85032 -5655 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-13 |
| Decision Date | 2002-06-03 |
| Summary: | summary |