The following data is part of a premarket notification filed by Specialized Health Products, Inc. with the FDA for Safety Cradle.
Device ID | K962149 |
510k Number | K962149 |
Device Name: | SAFETY CRADLE |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | SPECIALIZED HEALTH PRODUCTS, INC. 9721 S. ALTAMONT DR. Sandy, UT 84092 |
Contact | William E Mckay |
Correspondent | William E Mckay SPECIALIZED HEALTH PRODUCTS, INC. 9721 S. ALTAMONT DR. Sandy, UT 84092 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-04 |
Decision Date | 1996-10-11 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SAFETY CRADLE 74523669 1941770 Dead/Cancelled |
SPECIALIZED HEALTH PRODUCTS, INC. 1994-05-11 |