510(k) K800318
K800318 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI". The FDA issued a decision of Substantially Equivalent on March 10, 1980. The device falls under product code HBT (Applier, Hemostatic 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
- March 10, 1980
- Date Received
- February 12, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applier, Hemostatic Clip
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type