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510(k) K820952

OPTI-MIST by Corpak Co. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1982
Date Received
April 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

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  • K931921 — CORPAK GASTROSTOMY TUBE (June 9, 1995)
  • K932847 — CORPAK ENTERAL PUMP (June 17, 1994)
  • K902949 — CORPAK GRASPING FORCEPS (August 30, 1990)
  • K901501 — CORPAK GASTROSTOMY TUBE (June 11, 1990)
  • K882867 — CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE (September 21, 1988)
  • K853253 — CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI (November 5, 1985)

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