510(k) K822963
K822963 is an FDA 510(k) premarket notification submitted by Temp-Stik Corp. for the device "SURGICAL PRODUCTS, SKIN STAPLE REMOVER". The FDA issued a decision of Substantially Equivalent on November 8, 1982. The device falls under product code FZQ (Clip, Removable (Skin)), a Class I device regulated under 21 CFR 878.4320. Temp-Stik Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 1982
- Date Received
- October 5, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Removable (Skin)
- Device Class
- Class I
- Regulation Number
- 878.4320
- Review Panel
- SU
- Submission Type