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510(k) K822865

Device
SURGI-SCRUB V
Applicant
ACME UNITED CORP.
510(k) number
K822865
Product code
GEC  
Decision
Substantially Equivalent (SESE)
Decision date
1982-10-18
Date received
1982-09-27
Regulation
878.4800
Classification name
Brush, Scrub, Operating-room
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GEC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971473IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCKM-Pact Worldwide Management Corp.1997-07-07
K960621EXPANDACELL INSTRUMENT WIPEShippert Medical Technologies Corp.1996-04-01
K900691BIODYNE INSTRUMENT WIPESBio-Dyne, Inc.1990-03-08
K896085SURGI-BRUSHSparta Surgical Corp.1989-11-08
K875033STERILE SCRUBBY SCRUB BRUSHMedsurg Industries, Inc.1988-02-19
K875129STERI-CLENSAbsorbent Cotton Co., Inc.1988-02-18
K872823DELTA SCRUBPacific Biosystems, Inc.1988-01-07
K874653STERILE SURGICAL SCRUB BRUSHSurgikos, Inc.1987-12-30
K874741STERI-CLENS(TM) SURGICAL SCRUB SPONGEAbsorbent Cotton Co., Inc.1987-12-10
K870258BIOSCRUB SURGICAL SCRUB BRUSHK. W. Griffen Co.1987-02-24
K854232PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGESAmerican Pharmaseal Div. Ahsc1985-12-10
K844411SCRUB MATE DRY STERILE SCRUB BRUSHAmerican Sterilizer Co.1984-12-17
K843636FOAM CARE ONE STEP PREPBallard Medical Products1984-11-16
K831488DAVRON PROF. SCRUB BRUSH-DRY/STERILEMinnetonka, Inc.1983-06-08
K831226MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450Ballard Medical Products1983-05-16

Legacy Summary#

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FDA Review#

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