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FDA 510(k)

STOCKINETTE, STERILE TWO PLY W/PULL TABS

K-Number: K801532 · 1980-07-28

ApplicantThe Owenby Co.
Decision Date1980-07-28
Product CodeFQM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STOCKINETTE, STERILE TWO PLY W/PULL TABS 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 1980-07-28 under 510(k) number K801532. The device is classified under product code FQM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOCKINETTE, STERILE TWO PLY W/PULL TABS?

STOCKINETTE, STERILE TWO PLY W/PULL TABS is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is The Owenby Co.. The 510(k) number is K801532.

When did STOCKINETTE, STERILE TWO PLY W/PULL TABS receive FDA 510(k) clearance?

STOCKINETTE, STERILE TWO PLY W/PULL TABS received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801532.

Who is the listed applicant for STOCKINETTE, STERILE TWO PLY W/PULL TABS?

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 STOCKINETTE, STERILE TWO PLY W/PULL TABS?

The FDA product code for STOCKINETTE, STERILE TWO PLY W/PULL TABS is FQM.

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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, PROTECTIVEK801626ARM SLINGK801627COVER, LIMBK801531ARM SLINGK790210STOCKINETTE, TUBULAR UNBLEACHEDK780764NON-STERILE FOLDED GAUZE

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Related Devices (Code: FQM)

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.

K040936PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDELeda Co., Ltd.K040054BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLETheodore BarashK013244COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBEMed Gen, Inc.K952738SKIN SAVER SYSTEMSSkin Saver Systems, Inc.K872868ASPEN ESMARK BANDAGEAspen Laboratories, Inc.K840107TUBE-BANDAGE FOR HUMAN DIGITS 200Zens Health Care Products

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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