510(k) K823552
K823552 is an FDA 510(k) premarket notification submitted by American Cyanamid Co. for the device "APPOSE SKIN STAPLER & REMOVER". The FDA issued a decision of Substantially Equivalent on June 15, 1983. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. American Cyanamid Co. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 1983
- Date Received
- November 30, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type