Atlas FDA

CARE IV BURN PAD, CATALOG #'S BP2334,BP3472

FDA 510(k) clearance K855160 · decided 1986-01-24

Clearance details

K-number
K855160
Device name
CARE IV BURN PAD, CATALOG #'S BP2334,BP3472
Applicant
Howard Associates, Inc.
Decision
Substantially Equivalent
Date received
1985-12-26
Decision date
1986-01-24
Days to decision
29 days
Clearance type
Traditional
Advisory committee
Unknown
Location
Dallas, TX, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Howard Associates

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Recalls involving this device

No recalls on record reference this clearance.