The following data is part of a premarket notification filed by Amsco Sterile Recoveries, Inc. with the FDA for Surgeon's Gown.
| Device ID | K920404 |
| 510k Number | K920404 |
| Device Name: | SURGEON'S GOWN |
| Classification | Gown, Isolation, Surgical |
| Applicant | AMSCO STERILE RECOVERIES, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11201 |
| Contact | Carolann Kotula-cook |
| Correspondent | Carolann Kotula-cook AMSCO STERILE RECOVERIES, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11201 |
| Product Code | FYC |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812564039491 | K920404 | 000 |
| 00812564031938 | K920404 | 000 |
| 00812564031945 | K920404 | 000 |
| 00812564032034 | K920404 | 000 |
| 00812564032195 | K920404 | 000 |
| 00812564032713 | K920404 | 000 |
| 00812564033383 | K920404 | 000 |
| 00812564033413 | K920404 | 000 |
| 00812564033420 | K920404 | 000 |
| 00812564035981 | K920404 | 000 |
| 00812564039323 | K920404 | 000 |
| 00812564031921 | K920404 | 000 |