510(k) K905812
- Device
- INTRAUTERINE CATHETER SET
- Applicant
- EPCOM MEDICAL SYSTEMS, INC.
- 510(k) number
- K905812
- Product code
- HGS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-01-31
- Date received
- 1990-12-28
- Regulation
- 884.2700
- Classification name
- Catheter, Intrauterine And Introducer
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHERYL KUTCHERA
- Address
- 302 Lindbergh Ave. Livermore CA US 94550 94550
FDA Registration Numbers#
- 1066270
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HGS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914387 | TRANSCERVICAL INTRAUTERINE KIT | Telos Medical Corp. | 1991-12-30 |
Legacy Summary#
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FDA Review#
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