Atlas FDA

H.P. MEDICAL GRADE SILICONE TUBING

FDA 510(k) clearance K780470 · decided 1978-04-27

Clearance details

K-number
K780470
Device name
H.P. MEDICAL GRADE SILICONE TUBING
Applicant
Dow Corning Corp. Healthcare Industries Materials
Decision
Substantially Equivalent
Date received
1978-03-22
Decision date
1978-04-27
Days to decision
36 days
Clearance type
Traditional
Product code
KDL
Device class
2
Regulation number
876.5880
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
THE SOFT RINSE SYSTEM (P800060/S007)Dow Corning Corp. Healthcare Industries Materials1991-03-05
SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S010)Dow Corning Corp. Healthcare Industries Materials1985-11-18
SILSOFT (ELASTOFILCON A ) CONTACT LENS (P800020/S007)Dow Corning Corp. Healthcare Industries Materials1985-11-05
THE SOFT RINSE SYSTEM (P800060/S006)Dow Corning Corp. Healthcare Industries Materials1985-07-30
SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S008)Dow Corning Corp. Healthcare Industries Materials1984-10-31
THE SOFT RINSE SYSTEM (P800060/S005)Dow Corning Corp. Healthcare Industries Materials1984-04-04
SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S009)Dow Corning Corp. Healthcare Industries Materials1984-03-12
SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S004)Dow Corning Corp. Healthcare Industries Materials1983-11-09