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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngoscope, Rigid
510(k) Number K944686
Device Name FIBEROPTIC LARYNGOSCOPE HANDLE
Applicant
Fiberoptic Medical Products, Inc.
5100 Tilghman St., Suite 300
Allentown,  PA  18104
Applicant Contact RICHARD W HOLT
Correspondent
Fiberoptic Medical Products, Inc.
5100 Tilghman St., Suite 300
Allentown,  PA  18104
Correspondent Contact RICHARD W HOLT
Regulation Number868.5540
Classification Product Code
CCW  
Date Received09/23/1994
Decision Date 11/04/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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