The following data is part of a premarket notification filed by Ryan Medical, Inc. with the FDA for Safety, Blood Collection Tube Holder.
Device ID | K882880 |
510k Number | K882880 |
Device Name: | SAFETY, BLOOD COLLECTION TUBE HOLDER |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | RYAN MEDICAL, INC. 7106 CROSSROADS BLVD. SUITE 201 Brentwood, TN 37027 |
Contact | Ryan |
Correspondent | Ryan RYAN MEDICAL, INC. 7106 CROSSROADS BLVD. SUITE 201 Brentwood, TN 37027 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-11 |
Decision Date | 1988-08-09 |