510(k) K914365
K914365 is an FDA 510(k) premarket notification submitted by Davis & Geck, Inc. for the device "DEXON DISSECTING SPONGE". The FDA issued a decision of Substantially Equivalent on October 23, 1991. The device falls under product code GAK (Suture, Absorbable), a Class II device regulated under 21 CFR 878.4830. Davis & Geck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1991
- Date Received
- October 1, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Absorbable
- Device Class
- Class II
- Regulation Number
- 878.4830
- Review Panel
- SU
- Submission Type