The following data is part of a premarket notification filed by Dongkuk Trading Co., Ltd. with the FDA for Latex Finger Cots.
Device ID | K903073 |
510k Number | K903073 |
Device Name: | LATEX FINGER COTS |
Classification | Finger Cot |
Applicant | DONGKUK TRADING CO., LTD. K.P.O BOX 150 Seoul, Korea, KP |
Contact | H. S Park |
Correspondent | H. S Park DONGKUK TRADING CO., LTD. K.P.O BOX 150 Seoul, Korea, KP |
Product Code | LZB |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-12 |
Decision Date | 1990-09-12 |