The following data is part of a premarket notification filed by Surgical Technologies, Inc. with the FDA for Oscilflator.
| Device ID | K952566 |
| 510k Number | K952566 |
| Device Name: | OSCILFLATOR |
| Classification | Syringe, Balloon Inflation |
| Applicant | SURGICAL TECHNOLOGIES, INC. 2801 SOUTH DECKER LAKE LN. Salt Lake City, UT 84119 |
| Contact | John E Lincoln |
| Correspondent | John E Lincoln SURGICAL TECHNOLOGIES, INC. 2801 SOUTH DECKER LAKE LN. Salt Lake City, UT 84119 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-02 |
| Decision Date | 1995-08-31 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OSCILFLATOR 74494242 1973286 Dead/Cancelled |
SURGICAL TECHNOLOGIES, INC. 1994-02-25 |