510(k) K954903
- Device
- PEDI VAGINAL ASPIRATOR
- Applicant
- COOK UROLOGICAL, INC.
- 510(k) number
- K954903
- Product code
- HFC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-29
- Date received
- 1995-10-25
- Regulation
- 884.1050
- Classification name
- Aspirator, Endocervical
- 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
- TAMMY BACON
- Address
- 1100 W. Morgan St. P.O. Box 227 Spencer IN US 47460 47460
FDA Registration Numbers#
- 1216677
- 2246552
- 1820334
- 2648727
- 1825146
- 1319639
Source Documents#
Other 510(k) Records For Product Code HFC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974032 | ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR | A & A Medical, Inc. | 1997-12-22 |
| K960263 | CERVICAL MUCOUS ASPIRATION CATHETER | Cook Urological, Inc. | 1996-08-29 |
| K954102 | SELECTMUCUS | Select Medical Systems, Inc. | 1995-11-21 |
| K902242 | ENDOCERVICAL ASPIRATOR | Innovative Medical Products, Inc. | 1990-10-09 |
| K902032 | O. B. PACK IV | Customed, Inc. | 1990-09-28 |
| K902954 | OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) | Permobil AB | 1990-08-23 |
| K895403 | ASPIRETTE ENDOCERVICAL ASPIRATOR | Unimar, Inc. | 1989-11-29 |
| K821134 | DC PACK TM | Seamless Hospital Products Co. | 1982-06-22 |
| K812175 | ENDOCERVICAL ASPIRATOR | Fertility Instrumentation, Inc. | 1981-09-21 |
| K801238 | ACCU-PAP T ZONE SAMPLER | Robert Hasselbrack, M.D. | 1980-08-12 |
Legacy Summary#
summary
FDA Review#
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