510(k) K823649
K823649 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "THERMOELASTOMER HOT/COLD COMPRESS BK7186". The FDA issued a decision of Substantially Equivalent on January 21, 1983. The device falls under product code IME (Pack, Hot Or Cold, Reusable), a Class I device regulated under 21 CFR 890.5700. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1983
- Date Received
- December 6, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pack, Hot Or Cold, Reusable
- Device Class
- Class I
- Regulation Number
- 890.5700
- Review Panel
- PM
- Submission Type