The following data is part of a premarket notification filed by Kerma Medical Products, Inc. with the FDA for Moore Secure Cap.
Device ID | K931042 |
510k Number | K931042 |
Device Name: | MOORE SECURE CAP |
Classification | Accessory, Surgical Apparel |
Applicant | KERMA MEDICAL PRODUCTS, INC. 1801-P SARA DR. Chesapeake, VA 23320 |
Contact | Tony Ellison |
Correspondent | Tony Ellison KERMA MEDICAL PRODUCTS, INC. 1801-P SARA DR. Chesapeake, VA 23320 |
Product Code | LYU |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-01 |
Decision Date | 1994-04-13 |