510(k) K945179
- Device
- BOTTLE COLLECTION SET
- Applicant
- MEDGYN PRODUCTS, INC.
- 510(k) number
- K945179
- Product code
- HGF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-01-26
- Date received
- 1994-10-24
- Regulation
- 884.5070
- Classification name
- Source, Abortion Unit, Vacuum
- 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
- LAKSHMAN AGADI
- Address
- 328 N. Eisenhower Ln. Lombard IL US 60148 60148
FDA Registration Numbers#
- 1422634
- 1450908
- 1424263
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HGF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K905115 | BIOVISION ENDOCULAR PROBE | Douglas James Donaldson Compliance Services | 1991-02-11 |
| K904248 | MODEL GLASE 210 HOLMIUM LASER SYSTEM | Charles L. Rose and Co., Inc. | 1990-12-14 |
| K890787 | O-020 LASER INDIRECT OPHTHALMOSCOPE | Hgm Medical Laser Systems, Inc. | 1989-03-24 |
Legacy Summary#
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FDA Review#
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