510(k) K073675
K073675 is an FDA 510(k) premarket notification submitted by Gaymar Industries, Inc. for the device "T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP". The FDA issued a decision of Substantially Equivalent on May 8, 2008. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Gaymar Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 2008
- Date Received
- December 28, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pack, Hot Or Cold, Water Circulating
- Device Class
- Class II
- Regulation Number
- 890.5720
- Review Panel
- PM
- Submission Type