510(k) K883283
- Device
- DISPOSABLE AMNIOTOME
- Applicant
- GALENICA ENTERPRISES, INC.
- 510(k) number
- K883283
- Product code
- HGG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-10-18
- Date received
- 1988-08-04
- Regulation
- 884.5070
- Classification name
- Controller, Abortion Unit, Vacuum
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JACQUES R MARCOTTE
- Address
- C.P. 13 Ste-Therese Quebec Canada J7e 4h7 CA
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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