FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

SHAMROCK SAFETY BLOOD COLLECTION SET

K Number: K895705 · Decision Oct 10, 1989
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
5
Review Days
29

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Basic Information

Device Name
SHAMROCK SAFETY BLOOD COLLECTION SET
K Number
K895705
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5570
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Ryan Medical, Inc.
Date Received
September 11, 1989
Decision Date
October 10, 1989
Product Code
FMI
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FMI Needle, Hypodermic, Single Lumen

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Other Clearances by Ryan Medical, Inc.

K Number Device Name
K923090 SAF-T HOLDER MULTI SAMPLE LUER ADAPTER W/ BLOOD
K901729 SAF-T CLIK I.V. IN-LINE CONNECTOR & EXTENSION SET
K895481 SHAMROCK SAFETY WINGED INFUSION SET
K882880 SAFETY, BLOOD COLLECTION TUBE HOLDER