The following data is part of a premarket notification filed by Challenge Mfg., Inc. with the FDA for Cmi Tender Touch Ve #303tt And 404tt.
| Device ID | K910788 |
| 510k Number | K910788 |
| Device Name: | CMI TENDER TOUCH VE #303TT AND 404TT |
| Classification | Condom |
| Applicant | CHALLENGE MFG., INC. P.O. BOX 5877 Bend, OR 97708 |
| Contact | Emily Smith |
| Correspondent | Emily Smith CHALLENGE MFG., INC. P.O. BOX 5877 Bend, OR 97708 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-25 |
| Decision Date | 1991-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H671606TT1 | K910788 | 000 |
| H671600TT1 | K910788 | 000 |
| H671506TTL1 | K910788 | 000 |
| H671505TTL1 | K910788 | 000 |
| H671505TT1 | K910788 | 000 |
| H671444FC1 | K910788 | 000 |
| H671404TT1 | K910788 | 000 |
| H671303TTL1 | K910788 | 000 |
| H671303TT1 | K910788 | 000 |