Atlas FDA

ANSPACH ANGLED MICRONOSE ATTACHMENT

FDA 510(k) clearance K002903 · decided 2000-10-24

Clearance details

K-number
K002903
Device name
ANSPACH ANGLED MICRONOSE ATTACHMENT
Applicant
The Anspach Effort, Inc.
Decision
Substantially Equivalent
Date received
2000-09-18
Decision date
2000-10-24
Days to decision
36 days
Clearance type
Traditional
Product code
HBE
Device class
2
Regulation number
882.4310
Medical specialty
Neurology
Advisory committee
Neurology
Location
Palm Beach Gardens, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device is intend recall (Z-1902-2014)The Anspach Effort, Inc.2014-06-25