Atlas FDA

STERILE POLYHESIVE PBS DRESSING

FDA 510(k) clearance K890021 · decided 1989-06-01

Clearance details

K-number
K890021
Device name
STERILE POLYHESIVE PBS DRESSING
Applicant
Valleylab, Inc.
Decision
Substantially Equivalent for Some Indications
Date received
1989-01-04
Decision date
1989-06-01
Days to decision
148 days
Clearance type
Traditional
Product code
KGF
Device class
3
Medical specialty
Unknown
Advisory committee
Unknown
Location
Boulder, CO, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.