510(k) K854568
K854568 is an FDA 510(k) premarket notification submitted by American V. Mueller for the device "V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP". The FDA issued a decision of Substantially Equivalent on December 2, 1985. The device falls under product code GEF (Applier, Staple, Surgical,), a Class I device regulated under 21 CFR 878.4800. American V. Mueller has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1985
- Date Received
- November 14, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applier, Staple, Surgical,
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type