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510(k) K850423

Device
CONCEPT SUCTION SLEEVE
Applicant
CONCEPT, INC.
510(k) number
K850423
Product code
HTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1985-03-14
Date received
1985-02-04
Regulation
878.4800
Classification name
Instrument, Cutting, Orthopedic
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PENNY RASMUSSEN
Address
12707 U.S. 19 S. Clearwater FL US 33546 33546

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HTZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933933CEBOPLANESynvasive Technology, Inc.1994-04-15
K931737HEDLEYL INTRAMEDULLARY PREPARATION BRUSHSynvasive Technology, Inc.1994-01-07
K87088245 DEGREE SHAVERBowen & Company, Inc.1987-03-23
K853678KAMBIN SPINAL INSTRUMENT SETPilling Co.1985-09-24
K850527ARTHROSCOPY SUCTION BIOPSY PUNCHT. Korossurgical Instruments Corp.1985-03-14
K841980SIDE CUTTING SERRATED BLADEStainless Mfg., Inc.1984-08-15
K842774CODMAN SUCTION PUNCH-PRODUCT CODESCodman & Shurtleff, Inc.1984-07-27
K841978LATERAL RELEASE KNIFE 5MM & 7MMStainless Mfg., Inc.1984-06-19
K842111KOGAN ENDOSPECULUM 9-1/2J. Sklar Mfg. Co., Inc.1984-06-19
K841982MENISCOTOME 4MM & 5MMStainless Mfg., Inc.1984-06-19
K8419775MM DOUGLE EDGE RING CURETTEStainless Mfg., Inc.1984-06-19
K841976HOOK KNIFE 4MM & 5MMStainless Mfg., Inc.1984-06-19
K841975ROSETTE KNIFE 4MMStainless Mfg., Inc.1984-06-19
K841974RETROGRADE KNIFE 4MM & 5MMStainless Mfg., Inc.1984-06-19
K841973BANANA KNIFE SERRATEDStainless Mfg., Inc.1984-06-19

Legacy Summary#

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FDA Review#

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