510(k) K833704
K833704 is an FDA 510(k) premarket notification submitted by American Heyer Schulte for the device "AMER. V. MUELLER SURGICALSTAPLES-CARTR". The FDA issued a decision of Substantially Equivalent on December 29, 1983. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. American Heyer Schulte has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1983
- Date Received
- October 18, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type