510(k) K803177
K803177 is an FDA 510(k) premarket notification submitted by Duro-Med Ind., Inc. for the device "MOIST HEAT PACK". The FDA issued a decision of Substantially Equivalent on December 31, 1980. The device falls under product code IMA (Pack, Heat, Moist), a Class I device regulated under 21 CFR 890.5730. Duro-Med Ind., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 1980
- Date Received
- December 16, 1980
- 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