510(k) K915670
K915670 is an FDA 510(k) premarket notification submitted by Microaire for the device "MICROAIRE MODEL 2600". The FDA issued a decision of Substantially Equivalent on March 18, 1992. The device falls under product code GEF (Applier, Staple, Surgical,), a Class I device regulated under 21 CFR 878.4800. Microaire has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 1992
- Date Received
- December 19, 1991
- 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