510(k) K802783
K802783 is an FDA 510(k) premarket notification submitted by Hospital Products Intl. for the device "SURGEONS CHOICE STAPLE, REMOVE/IMPLANT". The FDA issued a decision of Substantially Equivalent on December 16, 1980. The device falls under product code GBN (Catheter, Pediatric, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 1980
- Date Received
- November 4, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Pediatric, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type