510(k) K931476
- Device
- NOVY CORNUAL CANNULATION SET
- Applicant
- COOK OB/GYN
- 510(k) number
- K931476
- Product code
- MOV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-07-28
- Date received
- 1993-03-24
- Regulation
- 884.4530
- Classification name
- Catheters, Salpingography
- 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
- DEXTER ELKINS
- Address
- 1100 W. Morgan St. P.O. Box 271 Spencer IN US 47460 47460
FDA Registration Numbers#
- 3014279513
- 1820334
- 1825146
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MOV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K180552 | Modified Novy Cornual Cannulation Set | Cook Incorporated | 2018-07-12 |
| K932436 | ECHOMARK INTRAUTERINE GUIDING CATHETER | Echocath, Inc. | 1995-11-16 |
| K931534 | OVAMED INTRAUTERINE ACCESS CATHETER | Ovamed Corp. | 1995-07-28 |
| K953314 | CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM | Conceptus, Inc. | 1995-07-28 |
Legacy Summary#
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FDA Review#
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