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510(k) K971067

DIGI-INJECTOR by Medical Instrument Development Laboratories, Inc. — Product Code MRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1997
Date Received
March 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Ophthalmic
Device Class
Class II
Regulation Number
880.5725
Review Panel
OP
Submission Type

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  • K932669 — SUPRA-VIT(TM) (June 3, 1994)
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  • K924222 — MID LABS, INC. VIT MATE (January 27, 1993)
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