The following data is part of a premarket notification filed by Greene International Corp. with the FDA for Surgical Garments.
| Device ID | K880484 |
| 510k Number | K880484 |
| Device Name: | SURGICAL GARMENTS |
| Classification | Gown, Isolation, Surgical |
| Applicant | GREENE INTERNATIONAL CORP. P.O. BOX:56-26 TAIPEI, TAIWAN (formosa) R.o.c., TW |
| Contact | Mary E Greene |
| Correspondent | Mary E Greene GREENE INTERNATIONAL CORP. P.O. BOX:56-26 TAIPEI, TAIWAN (formosa) R.o.c., TW |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-04 |
| Decision Date | 1988-06-27 |