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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Nasal
510(k) Number K942158
Device Name AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS
Applicant
Wfr/Aquaplast Corp.
P.O. Box 635
Wyckoff,  NJ  07481
Applicant Contact JOHN R KIRK
Correspondent
Wfr/Aquaplast Corp.
P.O. Box 635
Wyckoff,  NJ  07481
Correspondent Contact JOHN R KIRK
Regulation Number874.5800
Classification Product Code
EPP  
Date Received05/03/1994
Decision Date 07/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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