Atlas FDA

AEROSOL DELIVERY SYSTEMS

FDA 510(k) clearance K920842 · decided 1992-05-15

Clearance details

K-number
K920842
Device name
AEROSOL DELIVERY SYSTEMS
Applicant
Hospitak, Inc.
Decision
Substantially Equivalent
Date received
1992-02-24
Decision date
1992-05-15
Days to decision
81 days
Clearance type
Traditional
Product code
LRD
Device class
1
Regulation number
874.5220
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Lindenhurst, NY, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
AROMAPATCH (K984345)Envis, Inc.1999-03-19
AMSCO STERILE RECOVERIES SURGICAL PACKS (K932522)Amsco Sterile Recoveries, Inc.1994-09-09
MISTASSIST (K942789)The Merlin Corp.1994-08-12
THE EXPANDACELL EAR PACK (K940133)Denver Splint Co.1994-05-23
SURGICAL TRAY (STERILE) (K925022)Customed, Inc.1993-04-26

Recalls involving this device

No recalls on record reference this clearance.