The following data is part of a premarket notification filed by Medical Armor Corp. with the FDA for Protect-aids Underglove.
Device ID | K880439 |
510k Number | K880439 |
Device Name: | PROTECT-AIDS UNDERGLOVE |
Classification | Accessory, Surgical Apparel |
Applicant | MEDICAL ARMOR CORP. 11515 EIDELWEISS ST., N.W. Minneapolis, MN 55433 -2855 |
Contact | Dwight K Gahm |
Correspondent | Dwight K Gahm MEDICAL ARMOR CORP. 11515 EIDELWEISS ST., N.W. Minneapolis, MN 55433 -2855 |
Product Code | LYU |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-02 |
Decision Date | 1988-10-11 |