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FDA 510(k)

CENTURION VAGINAL SPECULUM

K-Number: K897100 · 1990-03-16

ApplicantTri-State Hospital Supply Corp.
Decision Date1990-03-16
Product CodeHIC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CENTURION VAGINAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Tri-State Hospital Supply Corp.. It received FDA 510(k) clearance on 1990-03-16 under 510(k) number K897100. The device is classified under product code HIC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTURION VAGINAL SPECULUM?

CENTURION VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 1990-03-16. The listed applicant is Tri-State Hospital Supply Corp.. The 510(k) number is K897100.

When did CENTURION VAGINAL SPECULUM receive FDA 510(k) clearance?

CENTURION VAGINAL SPECULUM received FDA 510(k) clearance on 1990-03-16, under 510(k) number K897100.

Who is the listed applicant for CENTURION VAGINAL SPECULUM?

The FDA 510(k) record lists Tri-State Hospital Supply Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTURION VAGINAL SPECULUM?

The FDA product code for CENTURION VAGINAL SPECULUM is HIC.

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Other records listing Tri-State Hospital Supply 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.

K080448CENTURION PROTECTIVE RESTRAINT, SCR SERIESK080524CENTURION SORBAVIEW OTCK942353CENTURION UMBILICAL CATHETERK945977CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSINGK931748CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYSK935491CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)

View all 16 devices →

Related Devices (Code: HIC)

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.

K955790PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAYTrylon Corp.K923656LIGHTING SOURCE SYSTEMGalenica Enterprises, Inc.K902516NEW LENGTH SUGITA APPLIERSSims Surgical, Inc.K853257SPECULITE DISPOSABLE VAGINAL LIGHTTrylon Associates, 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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