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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 K873163
Device Name VAN DELLEN IRRIGATING CYSTOTOME
Applicant
VAN DELLEN, LTD.
3810 E. 44TH ST., SUITE 301
P.O. BOX 27748
TUCSON,  AZ  85726
Applicant Contact ROGER DANHOF
Correspondent
VAN DELLEN, LTD.
3810 E. 44TH ST., SUITE 301
P.O. BOX 27748
TUCSON,  AZ  85726
Correspondent Contact ROGER DANHOF
Regulation Number886.4350
Classification Product Code
HNY  
Date Received08/11/1987
Decision Date 09/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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