510(k) K920978
K920978 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED". The FDA issued a decision of Substantially Equivalent on February 15, 1994. The device falls under product code GAN (Suture, Absorbable, Synthetic), a Class II device regulated under 21 CFR 878.4830. ETHICON, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 1994
- Date Received
- March 2, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Absorbable, Synthetic
- Device Class
- Class II
- Regulation Number
- 878.4830
- Review Panel
- SU
- Submission Type