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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K921707
Device Name PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
Applicant
PENTAX PRECISION INSTRUMENT CORP.
30 RAMLAND RD.
ORANGEBURG,  NY  10962
Applicant Contact LORRAINE SCHWARTZ
Correspondent
PENTAX PRECISION INSTRUMENT CORP.
30 RAMLAND RD.
ORANGEBURG,  NY  10962
Correspondent Contact LORRAINE SCHWARTZ
Regulation Number874.4760
Classification Product Code
EOB  
Date Received04/10/1992
Decision Date 07/01/1992
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
Recalls CDRH Recalls
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