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FDA 510(k)

INTERMED, INS STERILE WATER/SALINE

K-Number: K842166 · 1985-02-12

ApplicantIntermed, Inc.
Decision Date1985-02-12
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INTERMED, INS STERILE WATER/SALINE is the device name listed in this FDA 510(k) record. The listed applicant is Intermed, Inc.. It received FDA 510(k) clearance on 1985-02-12 under 510(k) number K842166. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERMED, INS STERILE WATER/SALINE?

INTERMED, INS STERILE WATER/SALINE is a medical device that received FDA 510(k) clearance on 1985-02-12. The listed applicant is Intermed, Inc.. The 510(k) number is K842166.

When did INTERMED, INS STERILE WATER/SALINE receive FDA 510(k) clearance?

INTERMED, INS STERILE WATER/SALINE received FDA 510(k) clearance on 1985-02-12, under 510(k) number K842166.

Who is the listed applicant for INTERMED, INS STERILE WATER/SALINE?

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

What is the FDA product code for INTERMED, INS STERILE WATER/SALINE?

The FDA product code for INTERMED, INS STERILE WATER/SALINE is BSY.

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Other records listing Intermed, 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.

K900857NON STERILE PARENTERAL SUPPLY KITK833126DRESSING CHANGE TRAYSK833573CENTRAL VEIN CATH. TRAY CC-20-1420K833574PERCUTANEOUS SHEATH INTRODUCER TRAYSK833139ACUTE HEMODIALYSIS TRAYSK833059SUCTION CATHETER TRAYS

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Related Devices (Code: BSY)

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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