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FDA 510(k)

VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES

K-Number: K031748 · 2003-08-27

ApplicantVitalcare Group, Inc.
Decision Date2003-08-27
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES 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 2003-08-27 under 510(k) number K031748. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES?

VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES is a medical device that received FDA 510(k) clearance on 2003-08-27. The listed applicant is Vitalcare Group, Inc.. The 510(k) number is K031748.

When did VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES receive FDA 510(k) clearance?

VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES received FDA 510(k) clearance on 2003-08-27, under 510(k) number K031748.

Who is the listed applicant for VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES?

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 STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES?

The FDA product code for VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES is EZL.

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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 GLOVEK992289VINYL POWDERED EXAM GLOVE / CAT.# 15-020K983016GAUZE, SPONGES, CAT # 11-003K983716VITALCARE DISPOSABLE VAGINAL SPECULUM

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Related Devices (Code: EZL)

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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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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