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FDA 510(k)

ROLLED NECK W/TAP

K-Number: K841412 · 1984-04-18

ApplicantWarne Surgical Products, Ltd.
Decision Date1984-04-18
Product CodeBTC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ROLLED NECK W/TAP is the device name listed in this FDA 510(k) record. The listed applicant is Warne Surgical Products, Ltd.. It received FDA 510(k) clearance on 1984-04-18 under 510(k) number K841412. The device is classified under product code BTC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROLLED NECK W/TAP?

ROLLED NECK W/TAP is a medical device that received FDA 510(k) clearance on 1984-04-18. The listed applicant is Warne Surgical Products, Ltd.. The 510(k) number is K841412.

When did ROLLED NECK W/TAP receive FDA 510(k) clearance?

ROLLED NECK W/TAP received FDA 510(k) clearance on 1984-04-18, under 510(k) number K841412.

Who is the listed applicant for ROLLED NECK W/TAP?

The FDA 510(k) record lists Warne Surgical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROLLED NECK W/TAP?

The FDA product code for ROLLED NECK W/TAP is BTC.

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Other records listing Warne Surgical Products, Ltd. 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.

K850694WSP CODE 4310 STRESSCATHK850696WSP CODE 4300 DIOMASTER DIAGNOSTICK850695WSP CODE 4301 DIOMASTER THERAPEUTICK850693WSP CODE 4315 PADTESTK841511HAEMATURIA CATHETERSK840687KIDNEY TRANSPLANT CATHETER

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Related Devices (Code: BTC)

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.

K181424PeDIAPedia, LLCK940220REBREATHER BAGSZefon Medical ProductsK932584BREATHING BAGSMerit Medical Systems, Inc.K932496PRECISION MED PRODUCTS, LTD. BREATHING BAGSPrecision Med Products, Ltd.K932581BREATHING BAGSMed-Plastics Intl., Inc.K932191BREATHING BAGSLife Shield Healthcare 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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