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FDA 510(k)

RICA OR SMIC SURGICAL INSTRUMENTS

K-Number: K801028 · 1980-05-20

ApplicantRobert I. Chien & Assoc., Inc.
Decision Date1980-05-20
Product CodeHXD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RICA OR SMIC SURGICAL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Robert I. Chien & Assoc., Inc.. It received FDA 510(k) clearance on 1980-05-20 under 510(k) number K801028. The device is classified under product code HXD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RICA OR SMIC SURGICAL INSTRUMENTS?

RICA OR SMIC SURGICAL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1980-05-20. The listed applicant is Robert I. Chien & Assoc., Inc.. The 510(k) number is K801028.

When did RICA OR SMIC SURGICAL INSTRUMENTS receive FDA 510(k) clearance?

RICA OR SMIC SURGICAL INSTRUMENTS received FDA 510(k) clearance on 1980-05-20, under 510(k) number K801028.

Who is the listed applicant for RICA OR SMIC SURGICAL INSTRUMENTS?

The FDA 510(k) record lists Robert I. Chien & Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RICA OR SMIC SURGICAL INSTRUMENTS?

The FDA product code for RICA OR SMIC SURGICAL INSTRUMENTS is HXD.

Related Clinical Trials

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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Other records listing Robert I. Chien & Assoc., Inc. 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.

K822151SURGICAL INSTRUMENTS REPRESENT. 4 CLASSK811632UNSTERILIZED LAPAROTOMY SPONGES (CHINA)K811631THERMOMETER (MADE IN CHINA)K810054RICA (DIAGNOSTIC INSTRUMENTS)K801819SURGICAL INSTRUMENTS

Related Devices (Code: HXD)

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.

K890372INTESTINAL CLAMPKinetic Medical ProductsK890381PARAMETRIUM CLAMPKinetic Medical ProductsK890371INTESTINAL CRUSHING CLAMPKinetic Medical ProductsK890368KIDNEY CLAMPKinetic Medical ProductsK874959VASCULAR CLAMPSolway, Inc.K872386C CLAMPMed-Tool, 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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