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FDA 510(k)

O.R. ARMBOARD COVER

K-Number: K813030 · 1982-01-18

ApplicantTecnol New Jersey Wound Care, Inc.
Decision Date1982-01-18
Product CodeFWZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

O.R. ARMBOARD COVER is the device name listed in this FDA 510(k) record. The listed applicant is Tecnol New Jersey Wound Care, Inc.. It received FDA 510(k) clearance on 1982-01-18 under 510(k) number K813030. The device is classified under product code FWZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O.R. ARMBOARD COVER?

O.R. ARMBOARD COVER is a medical device that received FDA 510(k) clearance on 1982-01-18. The listed applicant is Tecnol New Jersey Wound Care, Inc.. The 510(k) number is K813030.

When did O.R. ARMBOARD COVER receive FDA 510(k) clearance?

O.R. ARMBOARD COVER received FDA 510(k) clearance on 1982-01-18, under 510(k) number K813030.

Who is the listed applicant for O.R. ARMBOARD COVER?

The FDA 510(k) record lists Tecnol New Jersey Wound Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O.R. ARMBOARD COVER?

The FDA product code for O.R. ARMBOARD COVER is FWZ.

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Other records listing Tecnol New Jersey Wound Care, 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.

K913043MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKSK911891FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASKK911907FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VISK896193TECNOL LAZER(TM) SURGICAL MASKK894205TECNOL SILK STRIPK893702TECNOL GAITERS PRODUCT NUMBER 47725-010

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Related Devices (Code: FWZ)

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.

K960019RETRACTOR ARM CLAMPBiopsys Medical, Inc.K945415'LIL MAC ACCESSORY CLAMP(TM)D.L. Nelson and Assoc., Inc.K944779CARBON LIGHTS HAND SURGERY TABLEAllen Medical Systems, Inc.K935381KAPS POSITIONING ARMAndronic Devices, Ltd.K931037WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)Whitmore Ent., Inc.K926225SPONGE COUNTERAmerican Medical Manufacturer, 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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