Atlas FDA

WHITESIDE ACRYLIC CEMENT SPACER SLEEVE

FDA 510(k) clearance K844637 · decided 1985-06-19

Clearance details

K-number
K844637
Device name
WHITESIDE ACRYLIC CEMENT SPACER SLEEVE
Applicant
Dow Corning Corp. Healthcare Industries Materials
Decision
Substantially Equivalent
Date received
1984-11-28
Decision date
1985-06-19
Days to decision
203 days
Clearance type
Traditional
Product code
LTC
Device class
3
Medical specialty
Unknown
Advisory committee
Unknown
Location
P.O. Box 1767 Midland, 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