510(k) K790993
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 1979
- Date Received
- May 29, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pack, Hot Or Cold, Disposable
- Device Class
- Class I
- Regulation Number
- 890.5710
- Review Panel
- PM
- Submission Type