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FDA 510(k)

AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3

K-Number: K880587 · 1988-12-20

ApplicantC.I.S.A. Import Export C/O Larson and Taylor
Decision Date1988-12-20
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3 is the device name listed in this FDA 510(k) record. The listed applicant is C.I.S.A. Import Export C/O Larson and Taylor. It received FDA 510(k) clearance on 1988-12-20 under 510(k) number K880587. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3?

AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3 is a medical device that received FDA 510(k) clearance on 1988-12-20. The listed applicant is C.I.S.A. Import Export C/O Larson and Taylor. The 510(k) number is K880587.

When did AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3 receive FDA 510(k) clearance?

AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3 received FDA 510(k) clearance on 1988-12-20, under 510(k) number K880587.

Who is the listed applicant for AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3?

The FDA 510(k) record lists C.I.S.A. Import Export C/O Larson and Taylor as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3?

The FDA product code for AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3 is HIB.

Related Clinical Trials

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.

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Other records listing C.I.S.A. Import Export C/O Larson and Taylor 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.

K880586AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2K880588AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4

Related Devices (Code: HIB)

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.

K252208JFord Speculum Sleeve™Ford Medtech, LLCK130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLCK120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI LtdaK092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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