FDA.reportPublic FDA data

510(k) K852934

Device
PRECISION - COSMET CAPSULE COUPEUR
Applicant
PRECISION-COSMET CO., INC.
510(k) number
K852934
Product code
HNY  
Decision
Substantially Equivalent (SESE)
Decision date
1985-08-08
Date received
1985-07-09
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
ROBERT L ULLEN
Address
11140 Bren Rd., W. Minnetonka MN US 55343 55343

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
K874976PRISMA DISPOS. DOUBLE SHARP 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
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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases