FDA 510(k)

BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE

K-Number: K897005 · 1990-03-16

Decision Date1990-03-16

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Helix Medical, Inc.. It received FDA 510(k) clearance on 1990-03-16 under 510(k) number K897005. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE?

BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE is a medical device that received FDA 510(k) clearance on 1990-03-16. The listed applicant is Helix Medical, Inc.. The 510(k) number is K897005.

When did BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE receive FDA 510(k) clearance?

BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE received FDA 510(k) clearance on 1990-03-16, under 510(k) number K897005.

Who is the listed applicant for BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE?

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

What is the FDA product code for BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE?

The FDA product code for BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE is JOH.

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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.