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510(k) K820301

PLASMA POOLER HEAT SEALER by North American Biologicals, Inc. — Product Code KSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1982
Date Received
February 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Heat-Sealing
Device Class
Class I
Regulation Number
864.9750
Review Panel
HE
Submission Type

Other clearances by North American Biologicals, Inc.

  • K801219 — PLASMAPOOLER (October 31, 1980)
  • K801425 — RH CONTROL (July 14, 1980)
  • K781895 — BLOOD GROUP SUBSTANCE B (December 20, 1978)
  • K781862 — BLOOD GROUP SUBSTANCE A (December 20, 1978)
  • K781896 — BLOOD GROUP SUBSTANCE A,B (December 20, 1978)