510(k) K791653
K791653 is an FDA 510(k) premarket notification submitted by Tru-Eze Mfg. Co., Inc. for the device "REUSABLE MOIST HEAT PACK". The FDA issued a decision of Substantially Equivalent on September 7, 1979. The device falls under product code IMA (Pack, Heat, Moist), a Class I device regulated under 21 CFR 890.5730. Tru-Eze Mfg. Co., Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 1979
- Date Received
- August 14, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pack, Heat, Moist
- Device Class
- Class I
- Regulation Number
- 890.5730
- Review Panel
- PM
- Submission Type