510(k) K944054
- Device
- POWDER FREE SURGEON'S GLOVE
- Applicant
- ARENT FOX
- 510(k) number
- K944054
- Product code
- KGD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-11-17
- Date received
- 1994-08-19
- Regulation
- 876.1500
- Classification name
- Scissors For Cystoscope
- 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
- WAYNE H MATELSKI
- Address
- 1050 Connecticut Ave., NW Washington DC US 20036 20036
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KGD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K891902 | CHISELS- FREER, LUCAS, ALEXANDER, BISHOP | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
Legacy Summary#
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FDA Review#
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