The following data is part of a premarket notification filed by Suretex Prophylactics Ltd. with the FDA for Lifestyles, Contempo Or Private Label Strawberry, Vanilla, Or Banana Flavored Condom.
| Device ID | K000408 |
| 510k Number | K000408 |
| Device Name: | LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM |
| Classification | Condom |
| Applicant | SURETEX PROPHYLACTICS LTD. 1500 INDUSTRIAL RD. P.O. 1252 Dothan, AL 36302 |
| Contact | Lon D Mcinvain |
| Correspondent | Lon D Mcinvain SURETEX PROPHYLACTICS LTD. 1500 INDUSTRIAL RD. P.O. 1252 Dothan, AL 36302 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-08 |
| Decision Date | 2000-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813356000163 | K000408 | 000 |
| 18859798101012 | K000408 | 000 |
| 18859798100473 | K000408 | 000 |
| 18859798100077 | K000408 | 000 |
| 18859798100282 | K000408 | 000 |
| 30070907212722 | K000408 | 000 |
| 80070907101830 | K000408 | 000 |
| 30070907053004 | K000408 | 000 |
| 30070907064000 | K000408 | 000 |
| 00070907000199 | K000408 | 000 |
| 00070907000212 | K000408 | 000 |
| 30070907030005 | K000408 | 000 |
| 30070907298597 | K000408 | 000 |
| 30070907068008 | K000408 | 000 |
| 30070907026251 | K000408 | 000 |
| 00070907208724 | K000408 | 000 |
| 00070907209387 | K000408 | 000 |
| 00070907209417 | K000408 | 000 |
| 18859798101555 | K000408 | 000 |