BOTTLE COLLECTION SET
FDA 510(k) clearance K945179 · decided 1995-01-26
Clearance details
- K-number
- K945179
- Device name
- BOTTLE COLLECTION SET
- Applicant
- Medgyn Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-24
- Decision date
- 1995-01-26
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- HGF
- Device class
- 2
- Regulation number
- 884.5070
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Lombard, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BIOVISION ENDOCULAR PROBE (K905115) | Douglas James Donaldson Compliance Services | 1991-02-11 |
| MODEL GLASE 210 HOLMIUM LASER SYSTEM (K904248) | Charles L. Rose and Co., Inc. | 1990-12-14 |
| O-020 LASER INDIRECT OPHTHALMOSCOPE (K890787) | Hgm Medical Laser Systems, Inc. | 1989-03-24 |
Recalls involving this device
No recalls on record reference this clearance.