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510(k) K911503

EXMOOR SILICONE RUBBER SHEET by Exmoor Plastics , Ltd. — Product Code KHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1991
Date Received
April 3, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

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  • K973587 — EXMOOR TYMPANOCENTESIS KIT (TK/1) (January 23, 1998)

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