510(k) K830704
K830704 is an FDA 510(k) premarket notification submitted by Acme United Corp. for the device "ONE TIME DISPOSABLE SKIN STAPLER". The FDA issued a decision of Substantially Equivalent on April 12, 1983. The device falls under product code FZQ (Clip, Removable (Skin)), a Class I device regulated under 21 CFR 878.4320. Acme United Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1983
- Date Received
- March 7, 1983
- 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