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510(k) K942789

MISTASSIST by The Merlin Corp. — Product Code LRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1994
Date Received
June 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Ent Drug
Device Class
Class I
Regulation Number
874.5220
Review Panel
EN
Submission Type

Other clearances by The Merlin Corp.

  • K953055 — MISTASSIST BREATHING EXERCISER (February 8, 1996)

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  • K932522 — AMSCO STERILE RECOVERIES SURGICAL PACKS (September 9, 1994)
  • K940133 — THE EXPANDACELL EAR PACK (May 23, 1994)
  • K925022 — SURGICAL TRAY (STERILE) (April 26, 1993)
  • K920842 — AEROSOL DELIVERY SYSTEMS (May 15, 1992)