510(k) K822550
K822550 is an FDA 510(k) premarket notification submitted by American Medical Products, Inc. for the device "SAFE LOCK TITANIUM ADAPTER SET". The FDA issued a decision of Substantially Equivalent on Oct 13, 1982. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. American Medical Products, Inc. has 29 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 13, 1982
- Date Received
- Aug 24, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Peritoneal, Automatic Delivery
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type
- 510(k)