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510(k) K915075

NEBULIZER (DIRECT PATIENT INTERFACE) by Medi Nuclear Corp., Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1992
Date Received
November 8, 1991
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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  • K865107 — AERO-VENT AEROSOL UNIT (October 20, 1987)
  • K865093 — SAFE-T-SHIELD MOUTHPIECE (January 15, 1987)
  • K863996 — MODEL XE-103 XENON/MASTER II (November 4, 1986)
  • K813379 — RADIONUCLIDE DOSE CALIBRATOR (January 22, 1982)
  • K810819 — MEDI/NUCLEAR #XE-102 XENON/MASTER (April 14, 1981)

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