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FDA 510(k)

XOMED SILICONE BLOCK/STRIP

K-Number: K970910 · 1997-05-02

ApplicantXomed, Inc.
Decision Date1997-05-02
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

XOMED SILICONE BLOCK/STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1997-05-02 under 510(k) number K970910. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XOMED SILICONE BLOCK/STRIP?

XOMED SILICONE BLOCK/STRIP is a medical device that received FDA 510(k) clearance on 1997-05-02. The listed applicant is Xomed, Inc.. The 510(k) number is K970910.

When did XOMED SILICONE BLOCK/STRIP receive FDA 510(k) clearance?

XOMED SILICONE BLOCK/STRIP received FDA 510(k) clearance on 1997-05-02, under 510(k) number K970910.

Who is the listed applicant for XOMED SILICONE BLOCK/STRIP?

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

What is the FDA product code for XOMED SILICONE BLOCK/STRIP?

The FDA product code for XOMED SILICONE BLOCK/STRIP is KHJ.

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Other records listing Xomed, 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.

K002395MODEL 30 CLASSIC PNEUMATONOMETERK002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADEK002828XPS NITRO SYSTEMK002897TITANIUM MIDDLE EAR PROSTHESESK993653MICRO-FRANCE TROCARS AND ACCESSORIESK001148MEROGEL OTOLOGIC PACK

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Related Devices (Code: KHJ)

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.

K260266Tympendi™ (810)Grace Medical, Inc.K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech IncorporatedK161000Biodesign Otologic Repair GraftCook Biotech IncorporatedK132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAICeremed , Inc.K121360BIODESIGN ENT REPAIR GRAFTCook Biotech IncorpratedK122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINCeremed , Inc.

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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