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FDA 510(k)

PINT BOTTLE WELL

K-Number: K781364 · 1978-10-17

ApplicantBaxa Corp., Sub. of Cook Group, Inc.
Decision Date1978-10-17
Product CodeKYX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PINT BOTTLE WELL is the device name listed in this FDA 510(k) record. The listed applicant is Baxa Corp., Sub. of Cook Group, Inc.. It received FDA 510(k) clearance on 1978-10-17 under 510(k) number K781364. The device is classified under product code KYX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PINT BOTTLE WELL?

PINT BOTTLE WELL is a medical device that received FDA 510(k) clearance on 1978-10-17. The listed applicant is Baxa Corp., Sub. of Cook Group, Inc.. The 510(k) number is K781364.

When did PINT BOTTLE WELL receive FDA 510(k) clearance?

PINT BOTTLE WELL received FDA 510(k) clearance on 1978-10-17, under 510(k) number K781364.

Who is the listed applicant for PINT BOTTLE WELL?

The FDA 510(k) record lists Baxa Corp., Sub. of Cook Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PINT BOTTLE WELL?

The FDA product code for PINT BOTTLE WELL is KYX.

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Other records listing Baxa Corp., Sub. of Cook Group, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K910257BAXA PCA INFUSORK903159VALVE CONTROLLER FOR MICROMACRO COMPOUNDERK904225KWIKMIXK900585TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMPK873875BAXA EXACTA-MED PHARMACY PUMPK872743BAXA TUBING SETS (FOR PHARMACY PUMP)

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Related Devices (Code: KYX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K980109CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSERSangstat Medical Corp.K954181CANYONS BI-DIRECTIONAL CHECK VALVECanyon Medical ProductsK830571BOTTLE ADAPTERBurron Medical Products, Inc.K801008MULTI-AD FLUID DISPENSING PUMP MP-3000Burron Medical Products, Inc.K800362FLUID DISPENSING SYSTEMPharmaseal LaboratoriesK800437SYRINGE TIP CONNECTORBurron Medical Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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