The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for T-pump Localized Temperature Therapy Pump.
| Device ID | K073675 |
| 510k Number | K073675 |
| Device Name: | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | GAYMAR INDUSTRIES, INC. 140 PEARL STREET, SUITE 100 Buffalo, NY 14202 |
| Contact | Bethany J Gilbert |
| Correspondent | Bethany J Gilbert GAYMAR INDUSTRIES, INC. 140 PEARL STREET, SUITE 100 Buffalo, NY 14202 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-28 |
| Decision Date | 2008-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850007350147 | K073675 | 000 |
| 00850007350130 | K073675 | 000 |