The following data is part of a premarket notification filed by Medtech Products Ltd. with the FDA for Banana Ribbed.
| Device ID | K063401 |
| 510k Number | K063401 |
| Device Name: | BANANA RIBBED |
| Classification | Condom |
| Applicant | MEDTECH PRODUCTS LTD. 5876 155TH AVE. S.E. Bellevue, WA 98006 |
| Contact | Ravi Reddy |
| Correspondent | Ravi Reddy MEDTECH PRODUCTS LTD. 5876 155TH AVE. S.E. Bellevue, WA 98006 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-09 |
| Decision Date | 2007-03-26 |
| Summary: | summary |