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 |