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510(k) K875123

ORCEPAD by Alton Dean Medical, Inc. — Product Code HDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1988
Date Received
December 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Obstetrical, Ac-Powered (And Accessories)
Device Class
Class II
Regulation Number
884.4900
Review Panel
OB
Submission Type

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  • K771942 — TILT 10, CATALOG #S-2600 (October 27, 1977)
  • K770438 — CART, PROCEDURES (July 1, 1977)