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510(k) K820301

Device
PLASMA POOLER HEAT SEALER
Applicant
NORTH AMERICAN BIOLOGICALS, INC.
510(k) number
K820301
Product code
KSD  
Decision
Substantially Equivalent (SESE)
Decision date
1982-04-09
Date received
1982-02-04
Regulation
864.9750
Classification name
Device, Heat-sealing
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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