510(k) K860796
- Device
- DISPO-URETTE
- Applicant
- ROLAND J. ZWICK, INC.
- 510(k) number
- K860796
- Product code
- PCF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-04-08
- Date received
- 1986-03-04
- Regulation
- 884.1050
- Classification name
- Sampler, Endocervical
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROLAND J ZWICK
- Address
- 450 San Antonion Rd., Suite 21 Palo Alto CA US 94306 94306
FDA Registration Numbers#
- 1216677
- 1018470
- 2246552
- 1319639
- 1047843
- 3007800906
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PCF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K122658 | FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 | Femasys, Inc. | 2012-12-20 |
| K060320 | FEMECC ENDOCERVICAL CURETTE | Femspec LLC | 2006-07-28 |
| K882606 | EURO-MED ENDO-CURETTE | Buckman Co., Inc. | 1988-07-25 |
| K882404 | KEVOR-CURETTE | Euro-Med Intl. | 1988-07-08 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases