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FDA 510(k)

SHELL KRATON THERMO-PLASTIC RUBBER COMP.

K-Number: K803069 · 1980-12-22

ApplicantWarren E. Collins, Inc.
Decision Date1980-12-22
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SHELL KRATON THERMO-PLASTIC RUBBER COMP. is the device name listed in this FDA 510(k) record. The listed applicant is Warren E. Collins, Inc.. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K803069. The device is classified under product code BYP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHELL KRATON THERMO-PLASTIC RUBBER COMP.?

SHELL KRATON THERMO-PLASTIC RUBBER COMP. is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Warren E. Collins, Inc.. The 510(k) number is K803069.

When did SHELL KRATON THERMO-PLASTIC RUBBER COMP. receive FDA 510(k) clearance?

SHELL KRATON THERMO-PLASTIC RUBBER COMP. received FDA 510(k) clearance on 1980-12-22, under 510(k) number K803069.

Who is the listed applicant for SHELL KRATON THERMO-PLASTIC RUBBER COMP.?

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

What is the FDA product code for SHELL KRATON THERMO-PLASTIC RUBBER COMP.?

The FDA product code for SHELL KRATON THERMO-PLASTIC RUBBER COMP. is BYP.

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Other records listing Warren E. Collins, 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.

K925459GS-MODULAR (GOLD STANDARD - MODULAR)K912946COLLINS DIGITAL PULMONARY MANOMETERK871151THE SPIRA ELEKTRO 2K861227COLLINS PNEUMOTACH PFT SYSTEMK852102COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEMK831780METABOLIC EXERCISE TESTING SYSTEM

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Related Devices (Code: BYP)

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.

K955657NORTH STATE PLASTICS RESPIRATORY MOUTHPIECENorth State Plastics, Inc.K944512TRUZONE PFM DISPOSABLE MOUTHPIECEMonaghan Medical Corp.K893791BREATHING MOUTHPIECEDiemolding Corp.K872037AEROCHAMBERMonaghan Medical Corp.K865093SAFE-T-SHIELD MOUTHPIECEMedi Nuclear Corp., Inc.K863049INHALATION AIDBoehringer Ingelheim Pharmaceuticals, 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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