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510(k) K983755

NASAL DORSAL SERIES by Surgical Technology Laboratories, Inc. — Product Code FZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1998
Date Received
October 22, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Nose, Internal
Device Class
Class II
Regulation Number
878.3680
Review Panel
SU
Submission Type

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  • K982753 — SEARE BIOMEDICAL NASAL IMPLANTS (September 30, 1998)
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