510(k) K852604
K852604 is an FDA 510(k) premarket notification submitted by Clairol, Inc. for the device "MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK". The FDA issued a decision of Substantially Equivalent on August 12, 1985. The device falls under product code IRT (Pad, Heating, Powered), a Class II device regulated under 21 CFR 890.5740. Clairol, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1985
- Date Received
- June 19, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pad, Heating, Powered
- Device Class
- Class II
- Regulation Number
- 890.5740
- Review Panel
- PM
- Submission Type