The following data is part of a premarket notification filed by Associated Medical Products Co. with the FDA for Neurological Or Crani Trays (packs).
Device ID | K932221 |
510k Number | K932221 |
Device Name: | NEUROLOGICAL OR CRANI TRAYS (PACKS) |
Classification | General Surgery Tray |
Applicant | ASSOCIATED MEDICAL PRODUCTS CO. 3250 GORHAM AVE. St. Louis Park, MN 55426 |
Contact | Scott Weiss |
Correspondent | Scott Weiss ASSOCIATED MEDICAL PRODUCTS CO. 3250 GORHAM AVE. St. Louis Park, MN 55426 |
Product Code | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-07 |
Decision Date | 1997-03-19 |