The following data is part of a premarket notification filed by Radscan Medical Equipment, Inc. with the FDA for Radscan Equipment Slicker.
Device ID | K101350 |
510k Number | K101350 |
Device Name: | RADSCAN EQUIPMENT SLICKER |
Classification | Drape, Surgical |
Applicant | RADSCAN MEDICAL EQUIPMENT, INC. 23910 N. 19TH AVE BLDG 2 SUITE Phoenix, AZ 85085 |
Contact | Oran R Brown |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2010-05-14 |
Decision Date | 2011-01-04 |
Summary: | summary |