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FDA 510(k)

VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4

K-Number: K911613 · 1991-06-28

ApplicantExmoor Plastics , Ltd.
Decision Date1991-06-28
Product CodeLCR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 is the device name listed in this FDA 510(k) record. The listed applicant is Exmoor Plastics , Ltd.. It received FDA 510(k) clearance on 1991-06-28 under 510(k) number K911613. The device is classified under product code LCR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4?

VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 is a medical device that received FDA 510(k) clearance on 1991-06-28. The listed applicant is Exmoor Plastics , Ltd.. The 510(k) number is K911613.

When did VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 receive FDA 510(k) clearance?

VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 received FDA 510(k) clearance on 1991-06-28, under 510(k) number K911613.

Who is the listed applicant for VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4?

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

What is the FDA product code for VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4?

The FDA product code for VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 is LCR.

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Other records listing Exmoor Plastics , Ltd. 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.

K093863EPIDRUMK990366EXMOOR SUCTION CLEARANCE KITK980828EXMOOR MYRINGOTOMY KITK981143DILKES LASER/SUCTION CANNULAEK972700EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)K981088MILLS COLUMELLA PROSTHESIS

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Related Devices (Code: LCR)

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.

K060998QMS TOBRAMYCINSeradyn, Inc.K974029ACS TOBRAMYCINChiron Diagnostics Corp.K962818TOBRAMYCIN FLEX REAGENT CARTRIDGEDade Intl., Inc.K952568BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENTBeckman Instruments, Inc.K911940OPUS(R) TOBRAMYCINPb Diagnostic Systems, Inc.K854873INTRAOCULAR PRESSURE REDUCERMira, 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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