510(k) K760734
K760734 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "REGULAR AND WIDE SKIN STAPLES". The FDA issued a decision of Substantially Equivalent on November 3, 1976. The device falls under product code GDT (Staple, Removable (Skin)), a Class I device regulated under 21 CFR 878.4760. ETHICON, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1976
- Date Received
- September 28, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Removable (Skin)
- Device Class
- Class I
- Regulation Number
- 878.4760
- Review Panel
- SU
- Submission Type