510(k) K832820
K832820 is an FDA 510(k) premarket notification submitted by Gaymar Industries, Inc. for the device "MUL-T-BLANKET". The FDA issued a decision of Substantially Equivalent on Sep 26, 1983. 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
- Sep 26, 1983
- Date Received
- Aug 19, 1983
- 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