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FDA 510(k)

MEROCEL REINFORCED SILICONE SHEETS

K-Number: K953013 · 1995-08-29

ApplicantMerocel Corp.
Decision Date1995-08-29
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MEROCEL REINFORCED SILICONE SHEETS is the device name listed in this FDA 510(k) record. The listed applicant is Merocel Corp.. It received FDA 510(k) clearance on 1995-08-29 under 510(k) number K953013. 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 MEROCEL REINFORCED SILICONE SHEETS?

MEROCEL REINFORCED SILICONE SHEETS is a medical device that received FDA 510(k) clearance on 1995-08-29. The listed applicant is Merocel Corp.. The 510(k) number is K953013.

When did MEROCEL REINFORCED SILICONE SHEETS receive FDA 510(k) clearance?

MEROCEL REINFORCED SILICONE SHEETS received FDA 510(k) clearance on 1995-08-29, under 510(k) number K953013.

Who is the listed applicant for MEROCEL REINFORCED SILICONE SHEETS?

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

What is the FDA product code for MEROCEL REINFORCED SILICONE SHEETS?

The FDA product code for MEROCEL REINFORCED SILICONE SHEETS is KHJ.

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Other records listing Merocel Corp. 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.

K954919MEROCEL SOFT WOUND DRESSINGK953072MEROCEL VAGINAL PACKK943718EPISTAT-II NASAL CATHETERK940572MEROCEL(R) WOUND DRESSING (WITH HEMOSTATIC CLAIM)K935658MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINTK933152MEROCEL MEROSPLINT

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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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