510(k) K800535
K800535 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M DISPOSABLE SKIN STAPLER". The FDA issued a decision of Substantially Equivalent on April 4, 1980. The device falls under product code GDT (Staple, Removable (Skin)), a Class I device regulated under 21 CFR 878.4760. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1980
- Date Received
- March 10, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Removable (Skin)
- Device Class
- Class I
- Regulation Number
- 878.4760
- Review Panel
- SU
- Submission Type