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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystotome
510(k) Number K862709
Device Name MECHANICAL CYSTITOME
Applicant
Rudolph Beaver, Inc.
411 Waverley Oaks Rd.
P.O. Box 9097
Waltham,  MA  02154
Applicant Contact ROBERT P ZOLETTI
Correspondent
Rudolph Beaver, Inc.
411 Waverley Oaks Rd.
P.O. Box 9097
Waltham,  MA  02154
Correspondent Contact ROBERT P ZOLETTI
Regulation Number886.4350
Classification Product Code
HNY  
Date Received07/16/1986
Decision Date 08/01/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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