510(k) K830863
K830863 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "HANCOCK PERICARDIAL PATCH". The FDA issued a decision of Substantially Equivalent on August 31, 1983. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. Extracorporeal Medical Specialities, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1983
- Date Received
- March 18, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Device Class
- Class II
- Regulation Number
- 870.3470
- Review Panel
- CV
- Submission Type