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FDA 510(k)

VITALCARE DISPOSABLE VAGINAL SPECULUM

K-Number: K983716 · 1998-12-23

ApplicantVitalcare Group, Inc.
Decision Date1998-12-23
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VITALCARE DISPOSABLE VAGINAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Vitalcare Group, Inc.. It received FDA 510(k) clearance on 1998-12-23 under 510(k) number K983716. 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 VITALCARE DISPOSABLE VAGINAL SPECULUM?

VITALCARE DISPOSABLE VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 1998-12-23. The listed applicant is Vitalcare Group, Inc.. The 510(k) number is K983716.

When did VITALCARE DISPOSABLE VAGINAL SPECULUM receive FDA 510(k) clearance?

VITALCARE DISPOSABLE VAGINAL SPECULUM received FDA 510(k) clearance on 1998-12-23, under 510(k) number K983716.

Who is the listed applicant for VITALCARE DISPOSABLE VAGINAL SPECULUM?

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

What is the FDA product code for VITALCARE DISPOSABLE VAGINAL SPECULUM?

The FDA product code for VITALCARE DISPOSABLE VAGINAL SPECULUM is HIB.

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Other records listing Vitalcare Group, 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.

K060109OMI RETRACTABLE SAFETY SYRINGEK050906VITALCARE I.V. ADMINISTRATION SETK040916VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVEK031748VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGESK992289VINYL POWDERED EXAM GLOVE / CAT.# 15-020K983016GAUZE, SPONGES, CAT # 11-003

View all 8 devices →

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

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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