510(k) K823888
K823888 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M FRASCIA STAPLING SYSTEM". The FDA issued a decision of Substantially Equivalent on January 9, 1983. The device falls under product code GEF (Applier, Staple, Surgical,), a Class I device regulated under 21 CFR 878.4800. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1983
- Date Received
- December 27, 1982
- 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