510(k) K923656
- Device
- LIGHTING SOURCE SYSTEM
- Applicant
- GALENICA ENTERPRISES, INC.
- 510(k) number
- K923656
- Product code
- HIC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-09-08
- Date received
- 1992-07-13
- Regulation
- 884.4530
- Classification name
- Speculum, Vaginal, Nonmetal, Fiberoptic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BETTY MAILOT
- Address
- C.P. 13 Ste-Therese Quebec Canada J7e 4h7 CA
FDA Registration Numbers#
- 2027062
- 3003431869
- 3013530901
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HIC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K955790 | PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY | Trylon Corp. | 1996-03-21 |
| K902516 | NEW LENGTH SUGITA APPLIERS | Sims Surgical, Inc. | 1990-07-03 |
| K897100 | CENTURION VAGINAL SPECULUM | Tri-State Hospital Supply Corp. | 1990-03-16 |
| K853257 | SPECULITE DISPOSABLE VAGINAL LIGHT | Trylon Associates, Ltd. | 1985-12-27 |
Legacy Summary#
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FDA Review#
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