Atlas FDA

BASIN, ROUND WASH

FDA 510(k) clearance K760494 · decided 1976-11-12

Clearance details

K-number
K760494
Device name
BASIN, ROUND WASH
Applicant
Landmark Plastics
Decision
Substantially Equivalent
Date received
1976-08-23
Decision date
1976-11-12
Days to decision
81 days
Clearance type
Traditional
Product code
FNY
Device class
1
Regulation number
880.6730
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mchenry, IL, 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
AAP DOSIMETRY RELEASE OR BASIN SETS (K832826)American Hospital Supply Corp.1984-04-23
BASIN PACK (K802538)Texas Medical Products, Inc.1980-10-31
STERILE SPONGE BOWLS (K800440)Premium Plastics, Inc.1980-04-29
STERILIZATION PROCESS/PLACENTA BASIN (K792625)Procter & Gamble Mfg. Co.1980-01-16
8 EMESIS BASIN (K771733)Bemis Health Care1977-09-28
BASIN, RECTANGULAR WASH (K760495)Landmark Plastics1976-11-12
BASIN, LARGE OR SMALL (K760492)Landmark Plastics1976-11-12
BASIN, STERILE (#3200) (K760085)Concord Laboratories, Inc.1976-07-20

Recalls involving this device

No recalls on record reference this clearance.