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FDA 510(k)

UNIVERSAL MOUTHPIECE, #750

K-Number: K770586 · 1977-04-05

ApplicantSurgicot, Inc.
Decision Date1977-04-05
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL MOUTHPIECE, #750 is the device name listed in this FDA 510(k) record. The listed applicant is Surgicot, Inc.. It received FDA 510(k) clearance on 1977-04-05 under 510(k) number K770586. 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 UNIVERSAL MOUTHPIECE, #750?

UNIVERSAL MOUTHPIECE, #750 is a medical device that received FDA 510(k) clearance on 1977-04-05. The listed applicant is Surgicot, Inc.. The 510(k) number is K770586.

When did UNIVERSAL MOUTHPIECE, #750 receive FDA 510(k) clearance?

UNIVERSAL MOUTHPIECE, #750 received FDA 510(k) clearance on 1977-04-05, under 510(k) number K770586.

Who is the listed applicant for UNIVERSAL MOUTHPIECE, #750?

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

What is the FDA product code for UNIVERSAL MOUTHPIECE, #750?

The FDA product code for UNIVERSAL MOUTHPIECE, #750 is BYP.

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Other records listing Surgicot, 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.

K962605PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)K931270SURGICLEAN ENZYMATIC INSTRUMENT CLEANERK863122ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.K855101ASSERT TM BIOLOGICAL/CHEMICAL INDICATORK854631ASSERT EO BIOLOGICAL TEST PACKK854902SURGICOT STEAM TEST PACK

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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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