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510(k) K897093

Device
INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA.
Applicant
MICROLINE PENTAX, INC.
510(k) number
K897093
Product code
HNF  
Decision
Substantially Equivalent (SESE)
Decision date
1990-04-04
Date received
1989-12-20
Regulation
886.4350
Classification name
Scissors, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DE LAFORCADE
Address
199 Newbury St. Devers MA US 01923 01923

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HNF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K022840STEPHENS DISPOSABLE SCISSORSStephens Instruments2002-11-01
K873099MANUAL OPHTHALMIC SURGICAL INSTRUMENTSAlcon Laboratories1987-09-04
K85176813-550,13-560 WESCOTT SCOSSORS (EYE)Artiberia1985-06-20
K822151SURGICAL INSTRUMENTS REPRESENT. 4 CLASSRobert I. Chien & Assoc., Inc.1982-08-19
K821286IRIS SCISSORS STRAIGHT 4 1/2Conphar, Inc.1982-05-28
K821290LITTAUER SCISSORS 5 1/2Conphar, Inc.1982-05-28
K811245OPHTHALMIC SCISSORSKeeler Instruments, Inc.1981-07-31
K770040SCISSORS, STRABIMUS, 4 STRAIGHTJ. Sklar Mfg. Co., Inc.1977-01-14
K770041SCISSORS, STRABISMUS, 4 CURVEDJ. Sklar Mfg. Co., Inc.1977-01-14
K770019SCISSORS, IRISJ. Sklar Mfg. Co., Inc.1977-01-12
K760185SCISSORS, MICRO IRIS STRAIGHTV. Mueller O.V. Baxter Healthcare Corp.1976-08-04
K760188SCISSORS, MICRO IRIS CURVEDV. Mueller O.V. Baxter Healthcare Corp.1976-08-04
K760190SCISSORS, IRIS STRAIGHTV. Mueller O.V. Baxter Healthcare Corp.1976-08-04
K760326SURGICAL INSTRUMENTS, OPTHALMICDepuy, Inc.1976-08-04

Legacy Summary#

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FDA Review#

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