The following data is part of a premarket notification filed by Polymint Industrial Co. Ltd. with the FDA for Various Kits.
Device ID | K931634 |
510k Number | K931634 |
Device Name: | VARIOUS KITS |
Classification | First Aid Kit With Drug |
Applicant | POLYMINT INDUSTRIAL CO. LTD. 581 CONFERENCE PLACE Golden, CO 80401 |
Contact | Andrew M Reed |
Correspondent | Andrew M Reed POLYMINT INDUSTRIAL CO. LTD. 581 CONFERENCE PLACE Golden, CO 80401 |
Product Code | LRR |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-01 |
Decision Date | 1993-11-30 |