510(k) K791988
K791988 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "REPL. PISTON FOR TROUTMAN CORNEAL PUNCH". The FDA issued a decision of Substantially Equivalent on October 30, 1979. The device falls under product code HNJ (Punch, Corneo-Scleral), a Class I device regulated under 21 CFR 886.4350. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1979
- Date Received
- September 25, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Punch, Corneo-Scleral
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type