The following data is part of a premarket notification filed by Surgical Systems, Inc. with the FDA for Suture Tension Adjustment Reel.
| Device ID | K904136 |
| 510k Number | K904136 |
| Device Name: | SUTURE TENSION ADJUSTMENT REEL |
| Classification | Retention Device, Suture |
| Applicant | SURGICAL SYSTEMS, INC. KENDALL PROFESSIONAL BUILDING 9150 SOUTHWEST 87 AVENUE Miami, FL 33176 |
| Contact | Cohen, Md |
| Correspondent | Cohen, Md SURGICAL SYSTEMS, INC. KENDALL PROFESSIONAL BUILDING 9150 SOUTHWEST 87 AVENUE Miami, FL 33176 |
| Product Code | KGS |
| CFR Regulation Number | 878.4930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-06 |
| Decision Date | 1990-10-02 |