Atlas FDA

JAIN BLOOD SHIELD

FDA 510(k) clearance K913896 · decided 1992-03-06

Clearance details

K-number
K913896
Device name
JAIN BLOOD SHIELD
Applicant
Jain Surgical Equipment, Inc.
Decision
Substantially Equivalent
Date received
1991-08-30
Decision date
1992-03-06
Days to decision
189 days
Clearance type
Traditional
Product code
JOL
Device class
2
Regulation number
880.6740
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Kalamazoo, MI, US
Third-party review
No
Expedited review
No

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STERILE SALINE FOR CATHETER CARE (K974397)Baxter Healthcare Corp1998-02-10
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Recalls involving this device

No recalls on record reference this clearance.