510(k) K933604
- Device
- Qb Ii Blunt Dissector
- Applicant
- JOYCE M. SHOTWELL, M.D.
- 510(k) number
- K933604
- Product code
- FGS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-09-23
- Date received
- 1993-07-27
- Regulation
- 876.1500
- Classification name
- Carrier, Sponge, Endoscopic
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOYCE M SHOTWELL
- Address
- P.O. Box 743007 Dallas TX US 75374 75374
FDA Registration Numbers#
- 3010011359
- 3011137372
- 3010041511
Source Documents#
510(k) summary PDF not indicated by FDA