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510(k) K022840

Device
STEPHENS DISPOSABLE SCISSORS
Applicant
Stephens Instruments
510(k) number
K022840
Product code
HNF
Decision
Substantially Equivalent (SESE)
Decision date
2002-11-01
Date received
2002-08-27
Regulation
886.4350
Classification name
Scissors, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
ARCHANA JOHNSON
Address
2500 Sandersville Rd. Lexington KY US 40511 40511

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HNF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K897093INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA.Microline Pentax, Inc.1990-04-04
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