510(k) K791157
K791157 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "360 HEMOCLIP APPLIERS". The FDA issued a decision of Substantially Equivalent on June 27, 1979. The device falls under product code GDO (Applier, Surgical, Clip), a Class I device regulated under 21 CFR 878.4800. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 1979
- Date Received
- June 21, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applier, Surgical, Clip
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type