Atlas FDA

CEMENT DISPENSER CEMENT MIXER

FDA 510(k) clearance K790459 · decided 1979-03-28

Clearance details

K-number
K790459
Device name
CEMENT DISPENSER CEMENT MIXER
Applicant
Dow Corning Wright
Decision
Substantially Equivalent
Date received
1979-03-05
Decision date
1979-03-28
Days to decision
23 days
Clearance type
Traditional
Product code
JSG
Device class
1
Regulation number
866.2300
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (K882495)Lakewood Biochemical Co., Inc.1988-07-01
OF BASAL MEDIUM (K881550)Acumedia Manufacturers, Inc.1988-04-18
TRYPTOSE AGAR (K881558)Acumedia Manufacturers, Inc.1988-04-18
DEXTROSE TRYPTONE BROTH (K881523)Acumedia Manufacturers, Inc.1988-04-18
BLOOD AGAR BASE W/LOW PH (K881532)Acumedia Manufacturers, Inc.1988-04-18
TRYPTONE (K881557)Acumedia Manufacturers, Inc.1988-04-18
HEART INFUSION AGAR (K881542)Acumedia Manufacturers, Inc.1988-04-18
TRYPTOSE PHOSPHATE BROTH (K881563)Acumedia Manufacturers, Inc.1988-04-18
DEXTROSE AGAR (K881522)Acumedia Manufacturers, Inc.1988-04-18
MALT EXTRACT (K881545)Acumedia Manufacturers, Inc.1988-04-18
TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT (K881564)Acumedia Manufacturers, Inc.1988-04-18
SKIM MILK DEHYDRATED (K881554)Acumedia Manufacturers, Inc.1988-04-18

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS (P880076/S001)Dow Corning Wright1991-06-17