The following data is part of a premarket notification filed by Eagle Twe, Inc. with the FDA for Sheer Thin Aromas Blue Latex Condom.
| Device ID | K004016 |
| 510k Number | K004016 |
| Device Name: | SHEER THIN AROMAS BLUE LATEX CONDOM |
| Classification | Condom |
| Applicant | EAGLE TWE, INC. 2090 TUCKER INDUSTRIAL RD. Tucker, GA 30084 |
| Contact | Keith F Heintz |
| Correspondent | Keith F Heintz EAGLE TWE, INC. 2090 TUCKER INDUSTRIAL RD. Tucker, GA 30084 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-27 |
| Decision Date | 2001-03-27 |