510(k) K914365
- Device
- DEXON DISSECTING SPONGE
- Applicant
- DAVIS & GECK, INC.
- 510(k) number
- K914365
- Product code
- GAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-10-23
- Date received
- 1991-10-01
- Regulation
- 878.4830
- Classification name
- Suture, Absorbable
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHAN TAMSETT
- Address
- American Cynamid Company One Casper St. Danbury CT US 06810 06810
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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