The following data is part of a premarket notification filed by Custom Medical Products, Ltd. with the FDA for Head Sheet.
Device ID | K931455 |
510k Number | K931455 |
Device Name: | HEAD SHEET |
Classification | Drape, Surgical |
Applicant | CUSTOM MEDICAL PRODUCTS, LTD. P.O. BOX 8875 Asheville, NC 28814 |
Contact | Carolann Kotula-cook |
Correspondent | Carolann Kotula-cook CUSTOM MEDICAL PRODUCTS, LTD. P.O. BOX 8875 Asheville, NC 28814 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-23 |
Decision Date | 1994-05-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HEAD SHEET 72329306 0892489 Dead/Expired |
BROWN, ABIGAIL 1969-06-06 |