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510(k) K880253

BLAKEMORE RETAINER by Orthopedic Systems, Inc. — Product Code FEF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1988
Date Received
January 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

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