The following data is part of a premarket notification filed by Dresser Argus, Inc. with the FDA for Investigation Kit, Sexual Assault Determination.
| Device ID | K880208 |
| 510k Number | K880208 |
| Device Name: | INVESTIGATION KIT, SEXUAL ASSAULT DETERMINATION |
| Classification | Gauze/sponge, Internal |
| Applicant | DRESSER ARGUS, INC. 36 BRIDGE ST. Brooklyn, NY 11201 |
| Contact | Warren Frank |
| Correspondent | Warren Frank DRESSER ARGUS, INC. 36 BRIDGE ST. Brooklyn, NY 11201 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-15 |
| Decision Date | 1988-04-12 |