The following data is part of a premarket notification filed by Pride Health Care, Inc. with the FDA for Tmr-670.
Device ID | K931349 |
510k Number | K931349 |
Device Name: | TMR-670 |
Classification | Chair, Positioning, Electric |
Applicant | PRIDE HEALTH CARE, INC. 71 S. MAIN ST. Pittston, PA 18640 |
Contact | Kenneth Kemmerer |
Correspondent | Kenneth Kemmerer PRIDE HEALTH CARE, INC. 71 S. MAIN ST. Pittston, PA 18640 |
Product Code | INO |
CFR Regulation Number | 890.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-17 |
Decision Date | 1993-07-22 |