The following data is part of a premarket notification filed by Greene International Corp. with the FDA for Various Tyes Of Surgical Garments.
Device ID | K870617 |
510k Number | K870617 |
Device Name: | VARIOUS TYES OF SURGICAL GARMENTS |
Classification | Cap, 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 | FYF |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-12 |
Decision Date | 1987-03-09 |