The following data is part of a premarket notification filed by James Alexander Corp. with the FDA for Combination 6x-magnifier And Tweezers.
Device ID | K896413 |
510k Number | K896413 |
Device Name: | COMBINATION 6X-MAGNIFIER AND TWEEZERS |
Classification | First Aid Kit With Drug |
Applicant | JAMES ALEXANDER CORP. RD 3 BOX 192 Blairstown, NJ 07825 |
Contact | David Robinson |
Correspondent | David Robinson JAMES ALEXANDER CORP. RD 3 BOX 192 Blairstown, NJ 07825 |
Product Code | LRR |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-08 |
Decision Date | 1990-02-01 |