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FDA 510(k)

SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD

K-Number: K003015 · 2000-12-15

ApplicantSurgical Specialties Corp
Decision Date2000-12-15
Product CodeGAN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Specialties Corp. It received FDA 510(k) clearance on 2000-12-15 under 510(k) number K003015. The device is classified under product code GAN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD?

SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD is a medical device that received FDA 510(k) clearance on 2000-12-15. The listed applicant is Surgical Specialties Corp. The 510(k) number is K003015.

When did SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD receive FDA 510(k) clearance?

SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD received FDA 510(k) clearance on 2000-12-15, under 510(k) number K003015.

Who is the listed applicant for SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD?

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

What is the FDA product code for SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD?

The FDA product code for SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD is GAN.

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Other records listing Surgical Specialties Corp as applicant

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Related Devices (Code: GAN)

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.

K964072MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDETHICON, Inc.K960653MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)ETHICON, Inc.K951231ORTHOPEDIC PACKSSterile Concepts, Inc.K920978ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYEDETHICON, Inc.K895579POLYSORB SYNTHETIC ABSORBABLE SUTUREUnited States Surgical, A Division of Tyco HealthcK900198DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.American Cyanamid Co.

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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