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FDA 510(k)

BURN DRESSING PAD

K-Number: K780418 · 1978-04-10

ApplicantThe Owenby Co.
Decision Date1978-04-10
Product CodeFPY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BURN DRESSING PAD is the device name listed in this FDA 510(k) record. The listed applicant is The Owenby Co.. It received FDA 510(k) clearance on 1978-04-10 under 510(k) number K780418. The device is classified under product code FPY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BURN DRESSING PAD?

BURN DRESSING PAD is a medical device that received FDA 510(k) clearance on 1978-04-10. The listed applicant is The Owenby Co.. The 510(k) number is K780418.

When did BURN DRESSING PAD receive FDA 510(k) clearance?

BURN DRESSING PAD received FDA 510(k) clearance on 1978-04-10, under 510(k) number K780418.

Who is the listed applicant for BURN DRESSING PAD?

The FDA 510(k) record lists The Owenby Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BURN DRESSING PAD?

The FDA product code for BURN DRESSING PAD is FPY.

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Other records listing The Owenby Co. 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.

K801628RESTRAINT, PROTECTIVEK801532STOCKINETTE, STERILE TWO PLY W/PULL TABSK801626ARM SLINGK801627COVER, LIMBK801531ARM SLINGK790210STOCKINETTE, TUBULAR UNBLEACHED

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Related Devices (Code: FPY)

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.

K930759CP & S STERILE BURN SHEETConsolidated Products & Services, Inc.K921471BURNSHIELD TRAUMA DRESSINGLevtrade Intl. (Pty) , Ltd.K921470BURNSHIELD FIRE BLANKETLevtrade Intl. (Pty) , Ltd.K926290BURN SHEETGam Industries, Inc.K900441BURNS CASUALTY SHEETPilgrim Medical ServicesK900442BURNS CASUALTY SHEET BURN ROLLPilgrim Medical Services

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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