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FDA 510(k)

AQUA SPRAY

K-Number: K971941 · 1997-08-14

ApplicantBoyd Industries, Inc.
Decision Date1997-08-14
Product CodeGEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AQUA SPRAY is the device name listed in this FDA 510(k) record. The listed applicant is Boyd Industries, Inc.. It received FDA 510(k) clearance on 1997-08-14 under 510(k) number K971941. The device is classified under product code GEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUA SPRAY?

AQUA SPRAY is a medical device that received FDA 510(k) clearance on 1997-08-14. The listed applicant is Boyd Industries, Inc.. The 510(k) number is K971941.

When did AQUA SPRAY receive FDA 510(k) clearance?

AQUA SPRAY received FDA 510(k) clearance on 1997-08-14, under 510(k) number K971941.

Who is the listed applicant for AQUA SPRAY?

The FDA 510(k) record lists Boyd Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUA SPRAY?

The FDA product code for AQUA SPRAY is GEY.

Related Clinical Trials

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.

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Other records listing Boyd Industries, 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.

K020833BOYD DELIVERY UNIT

Related Devices (Code: GEY)

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.

K050519ADVANCED TURBO DRIVE SYSTEMLinvatec Corp.K020621ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDSArthrocare Corp.K012738SYMPHONY GRAFT DELIVERY SYSTEM (GDS)DepuyacromedK972308MEDNEXT 1000 DRILLMednext, Inc.K971782BONE AND MARROW COLLECTION SYSTEM KITBiomedical Ent., Inc.K971268BONE & MARROW CLLECTION SYSTEMBiomedical International Corp.

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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