The following data is part of a premarket notification filed by Amsco Sterile Recoveries, Inc. with the FDA for Sterile Surgeon's Gown.
| Device ID | K920405 |
| 510k Number | K920405 |
| Device Name: | STERILE SURGEON'S GOWN |
| Classification | Gown, Surgical |
| Applicant | AMSCO STERILE RECOVERIES, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11201 |
| Contact | Carolann Dotula-cook |
| Correspondent | Carolann Dotula-cook AMSCO STERILE RECOVERIES, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11201 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-31 |
| Decision Date | 1992-08-18 |