510(k) K803050
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1980
- Date Received
- December 2, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sprays, Synthetic, Smear
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type