510(k) K800162
- Device
- ONCE TM
- Applicant
- G.D. SEARLE AND CO.
- 510(k) number
- K800162
- Product code
- HDW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-02-11
- Date received
- 1980-01-25
- Regulation
- 884.5350
- Classification name
- Diaphragm, Contraceptive (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 1216677
- 3011014178
- 3013942365
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HDW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140305 | CAYA CONTOURED DIAPHRAGM | Kessel Medintim GmbH | 2014-08-26 |
| K080040 | ORTHO ALL-FLEX DIAPHRAGM | Johnson & Johnson Produtos Profissionais Ltda. | 2008-08-25 |
| K063223 | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS | CooperSurgical, Inc. | 2008-01-23 |
Legacy Summary#
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FDA Review#
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