510(k) K771002
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 1977
- Date Received
- June 2, 1977
- 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