510(k) K833357
K833357 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "VYDAX 525-550 & 5100 FLUOROTELOMER". The FDA issued a decision of Substantially Equivalent on December 12, 1983. 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
- December 12, 1983
- Date Received
- September 28, 1983
- 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