510(k) K950714
- Device
- COOK INSEMINATION CUP
- Applicant
- COOK UROLOGICAL, INC.
- 510(k) number
- K950714
- Product code
- HDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-05-11
- Date received
- 1995-02-15
- Regulation
- 884.5250
- Classification name
- Cap, Cervical
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DARCY JOB
- Address
- 1100 W. Morgan St. P.O. Box 271 Spencer IN US 47460 47460
FDA Registration Numbers#
- 1216677
- 3003775072
- 3038597712
- 3005630901
- 1825146
- 2246552
- 3005136445
- 3013382619
- 1820334
- 9612445
Source Documents#
Other 510(k) Records For Product Code HDR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242031 | Béa Applicator (BAP-GB-01) | Stepone Fertility Ltd (T/A Béa Fertility) | 2025-04-02 |
| K222969 | FERTI-LILY Conception Cup | Rosesta Medical BV | 2023-06-23 |
| K993953 | OVES CERVICAL CAP | Veos , Ltd. | 2000-03-21 |
| K945131 | IMAGYN INTRAUTERINE INSEMINATION DEVICE | Imagyn Medical, Inc. | 1995-05-15 |
| K902171 | MINISPACE(TM) IUI CATHETER | Pharmacia, Inc. | 1990-10-05 |
| K902694 | COAXIAL CATHETER SET | Cook Ob/Gyn | 1990-08-28 |
| K896960 | INTRAUTERINE INSEMINATION CATHETERS | C.R. Bard, Inc. | 1990-06-26 |
| K900316 | MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES | Irvine Scientific | 1990-04-16 |
| K900308 | SPERM SELECT SYSTEM | Pharmacia, Inc. | 1990-04-13 |
| K900162 | DGH A-SAN PROBE HOLDER | Jedmed Instrument Co. | 1990-02-16 |
| K894405 | HTF WITH ALBUMIN (CATALOG NO. 9994) | Irvine Scientific | 1989-09-22 |
| K894432 | MODIFIED HAM'S F-10 W/ALBUMIN | Irvine Scientific | 1989-09-22 |
| K894264 | KDF-2.3 | Unimar, Inc. | 1989-08-15 |
| K890301 | SHEPARD INTRAUTERINE INSEMINATION CATHETER | Cook Ob/Gyn | 1989-03-31 |
| K884696 | RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET | Laboratoire Ccd C/O Washington Regulatory Services | 1989-01-27 |
Legacy Summary#
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FDA Review#
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