The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Milex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing Diaphragms, Wideseal Diaphragms.
| Device ID | K063223 |
| 510k Number | K063223 |
| Device Name: | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS |
| Classification | Diaphragm, Contraceptive (and Accessories) |
| Applicant | COOPERSURGICAL, INC. 543 LONG HILL AVE. Shelton, CT 06484 |
| Contact | Joseph Azary |
| Correspondent | Joseph Azary COOPERSURGICAL, INC. 543 LONG HILL AVE. Shelton, CT 06484 |
| Product Code | HDW |
| CFR Regulation Number | 884.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-24 |
| Decision Date | 2008-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937001183 | K063223 | 000 |
| 00888937001020 | K063223 | 000 |
| 00888937001037 | K063223 | 000 |
| 00888937001044 | K063223 | 000 |
| 00888937001051 | K063223 | 000 |
| 00888937001068 | K063223 | 000 |
| 00888937001075 | K063223 | 000 |
| 00888937001082 | K063223 | 000 |
| 00888937001099 | K063223 | 000 |
| 00888937001105 | K063223 | 000 |
| 00888937001112 | K063223 | 000 |
| 00888937001129 | K063223 | 000 |
| 00888937001136 | K063223 | 000 |
| 00888937001143 | K063223 | 000 |
| 00888937001150 | K063223 | 000 |
| 00888937001167 | K063223 | 000 |
| 60888937001176 | K063223 | 000 |
| 00888937001013 | K063223 | 000 |