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FDA 510(k)

DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.

K-Number: K900198 · 1990-07-05

ApplicantAmerican Cyanamid Co.
Decision Date1990-07-05
Product CodeGAN
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. is the device name listed in this FDA 510(k) record. The listed applicant is American Cyanamid Co.. It received FDA 510(k) clearance on 1990-07-05 under 510(k) number K900198. The device is classified under product code GAN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.?

DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. is a medical device that received FDA 510(k) clearance on 1990-07-05. The listed applicant is American Cyanamid Co.. The 510(k) number is K900198.

When did DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. receive FDA 510(k) clearance?

DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. received FDA 510(k) clearance on 1990-07-05, under 510(k) number K900198.

Who is the listed applicant for DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.?

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

What is the FDA product code for DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.?

The FDA product code for DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. is GAN.

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Other records listing American Cyanamid Co. 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.

K930992FLEXON AND STAINLESS STEEL SUTURESK931056DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RINGK921696CUTTING AND COAGULATION DEVICES AND ACCESSORIESK922348VALTRAC(R) INTRODUCER FORCEPK896946COATED NOVAFIL, POLYBUTESTER, MESHK823552APPOSE SKIN STAPLER & REMOVER

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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.

K003015SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBDSurgical Specialties CorpK964072MONOCRYL (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 Healthc

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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