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FDA 510(k)

EXMOOR SILICONE RUBBER SHEET

K-Number: K911503 · 1991-11-19

ApplicantExmoor Plastics , Ltd.
Decision Date1991-11-19
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EXMOOR SILICONE RUBBER SHEET 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 1991-11-19 under 510(k) number K911503. 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 EXMOOR SILICONE RUBBER SHEET?

EXMOOR SILICONE RUBBER SHEET is a medical device that received FDA 510(k) clearance on 1991-11-19. The listed applicant is Exmoor Plastics , Ltd.. The 510(k) number is K911503.

When did EXMOOR SILICONE RUBBER SHEET receive FDA 510(k) clearance?

EXMOOR SILICONE RUBBER SHEET received FDA 510(k) clearance on 1991-11-19, under 510(k) number K911503.

Who is the listed applicant for EXMOOR SILICONE RUBBER SHEET?

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 EXMOOR SILICONE RUBBER SHEET?

The FDA product code for EXMOOR SILICONE RUBBER SHEET is KHJ.

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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: 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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