510(k) K791176
K791176 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M COLD/HOT WATER BAG AND WRAP". The FDA issued a decision of Substantially Equivalent on July 30, 1979. The device falls under product code FPF (Bottle, Hot/Cold Water), a Class I device regulated under 21 CFR 880.6085. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 1979
- Date Received
- June 25, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bottle, Hot/Cold Water
- Device Class
- Class I
- Regulation Number
- 880.6085
- Review Panel
- HO
- Submission Type