TRANSWARMER
Pack, Hot Or Cold, Disposable
PRISM TECHNOLOGIES, INC.
The following data is part of a premarket notification filed by Prism Technologies, Inc. with the FDA for Transwarmer.
Pre-market Notification Details
| Device ID | K934631 |
| 510k Number | K934631 |
| Device Name: | TRANSWARMER |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | PRISM TECHNOLOGIES, INC. 7492 REINDEER TRAIL San Antonio, TX 78238 |
| Contact | Merle M Smith |
| Correspondent | Merle M Smith PRISM TECHNOLOGIES, INC. 7492 REINDEER TRAIL San Antonio, TX 78238 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-24 |
| Decision Date | 1994-02-03 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30888937025768 | K934631 | 000 |
Trademark Results [TRANSWARMER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRANSWARMER 74367574 1843571 Live/Registered |
COOPERSURGICAL, INC. 1993-03-12 |
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