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FDA 510(k)

FIBERFILL SGP

K-Number: K023819 · 2003-03-26

ApplicantPentron Clinical Technologies
Decision Date2003-03-26
Product CodeEKM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIBERFILL SGP is the device name listed in this FDA 510(k) record. The listed applicant is Pentron Clinical Technologies. It received FDA 510(k) clearance on 2003-03-26 under 510(k) number K023819. The device is classified under product code EKM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBERFILL SGP?

FIBERFILL SGP is a medical device that received FDA 510(k) clearance on 2003-03-26. The listed applicant is Pentron Clinical Technologies. The 510(k) number is K023819.

When did FIBERFILL SGP receive FDA 510(k) clearance?

FIBERFILL SGP received FDA 510(k) clearance on 2003-03-26, under 510(k) number K023819.

Who is the listed applicant for FIBERFILL SGP?

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

What is the FDA product code for FIBERFILL SGP?

The FDA product code for FIBERFILL SGP is EKM.

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Other records listing Pentron Clinical Technologies 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.

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Related Devices (Code: EKM)

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.

K073369EI DOWNPAK BARRIER SLEEVESHu-Friedy Mfg. Co., Inc.K070246DOWN PAKEndo Twinn B.V.K051573TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)Dr. Howard Martin, P.A.K042870ENDO TWINNEndo Twinn B.V.K971641ANTIBACTERIAL GUTTA PERCHADr. Howard Martin, P.A.K970134THERMAPREP PLUS OVENTulsa Dental Products, Ltd.

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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