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510(k) K851797

53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH by Artiberia — Product Code FFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1985
Date Received
April 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Rectal
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

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