Atlas FDA

DISPOSABLE SYRINGE FILTERS

FDA 510(k) clearance K840556 · decided 1984-03-05

Clearance details

K-number
K840556
Device name
DISPOSABLE SYRINGE FILTERS
Applicant
Corning Medical & Scientific
Decision
Substantially Equivalent
Date received
1984-02-08
Decision date
1984-03-05
Days to decision
26 days
Clearance type
Traditional
Product code
KET
Device class
1
Regulation number
864.3010
Medical specialty
Pathology
Advisory committee
Pathology
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
DISPOSABLE STERILE SYRINGE FILTERS (K875122)Corning Medical & Scientific1988-01-12
PCTE MICROPOROUS MEMBRANE FILTER (K870196)Poretics Corp.1987-05-12
CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON (K844671)Corning Medical & Scientific1985-02-25
STERILIZATION PROCESS/OUTERWRAP (K792633)Procter & Gamble Mfg. Co.1980-01-11

Recalls involving this device

No recalls on record reference this clearance.