The following data is part of a premarket notification filed by Surgin Surgical Instrumentation, Inc. with the FDA for Surgical Lift Sheet.
Device ID | K942807 |
510k Number | K942807 |
Device Name: | SURGICAL LIFT SHEET |
Classification | Lift, Patient, Non-ac-powered |
Applicant | SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin, CA 92680 |
Contact | Don Haas |
Correspondent | Don Haas SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin, CA 92680 |
Product Code | FSA |
CFR Regulation Number | 880.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-14 |
Decision Date | 1994-08-02 |