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510(k) K984345

AROMAPATCH by Envis, Inc. — Product Code LRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1999
Date Received
December 4, 1998
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

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  • K925022 — SURGICAL TRAY (STERILE) (April 26, 1993)
  • K920842 — AEROSOL DELIVERY SYSTEMS (May 15, 1992)