Atlas FDA

AUGUSTINE GUIDE(TM) KIT

FDA 510(k) clearance K912690 · decided 1991-09-04

Clearance details

K-number
K912690
Device name
AUGUSTINE GUIDE(TM) KIT
Applicant
Augustine Medical, Inc.
Decision
Substantially Equivalent
Date received
1991-06-18
Decision date
1991-09-04
Days to decision
78 days
Clearance type
Traditional
Product code
BSR
Device class
1
Regulation number
868.5790
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Eden Prairie, MN, US
Third-party review
No
Expedited review
No

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AIRGUIDE STYLETTE (K950713)Polamedco, Inc.1995-05-17
FLEXTITIP STYLETTE (K950380)Polamedco, Inc.1995-02-10
STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE (K944729)Coast Medical, Inc.1994-12-21
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Recalls involving this device

No recalls on record reference this clearance.