510(k) K884685
- Device
- Rocket Fetal Blood Sampling Tray
- Applicant
- A & A MEDICAL, INC.
- 510(k) number
- K884685
- Product code
- HGW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-01-12
- Date received
- 1988-11-08
- Regulation
- 884.1560
- Classification name
- Sampler, Blood, Fetal
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CEDRIC K BERNBERG
- Address
- 31a Business Park Dr. Branford CT US 06405 06405
Source Documents#
510(k) summary PDF not indicated by FDA