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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Vaginal, Nonmetal
510(k) Number K922154
Device Name INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION
Applicant
Olsen Electrosurgical, Inc.
2100 Meridian Park Blvd.
Concord,  CA  94520
Applicant Contact EUGENE W OLSEN
Correspondent
Olsen Electrosurgical, Inc.
2100 Meridian Park Blvd.
Concord,  CA  94520
Correspondent Contact EUGENE W OLSEN
Regulation Number884.4530
Classification Product Code
HIB  
Date Received05/07/1992
Decision Date 04/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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