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510(k) K874976

Device
PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME
Applicant
ADVANCED SURGICAL PRODUCTS, INC.
510(k) number
K874976
Product code
HNY  
Decision
Substantially Equivalent (SESE)
Decision date
1988-04-13
Date received
1987-12-02
Regulation
886.4350
Classification name
Cystotome
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TODD J HESSEL
Address
744 Goddard Chesterfield MO US 63017 63017

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HNY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K961524STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORSSterilab, Inc.1996-05-16
K880345CYSTOTOMES/KNIFESMyocure, Inc.1988-05-03
K875001PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.1988-04-13
K874997PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.1988-04-13
K874993PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.1988-04-13
K874983PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.1988-04-13
K874975PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOMEAdvanced Surgical Products, Inc.1988-04-13
K873163VAN DELLEN IRRIGATING CYSTOTOMEVan Dellen, Ltd.1987-09-04
K871365CAPSULECTOMER CYSTOTOMENoetix, Inc.1987-04-16
K870439LOOK IRRIGATING CYSTOTOMESLook, Inc.1987-02-20
K862709MECHANICAL CYSTITOMERudolph Beaver, Inc.1986-08-01
K852934PRECISION - COSMET CAPSULE COUPEURPrecision-Cosmet Co., Inc.1985-08-08
K841101CLAYMAN-PAREL CAPSULE COUPEURMiami Eye Technology, Inc.1984-05-16
K840475CYSTOTOME, 140-SCilco, Inc.1984-04-05
K840660POSTERIOR CAPSULOTOMY CYSTITOMESharpoint, Inc.1984-03-16

Legacy Summary#

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FDA Review#

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