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FDA 510(k)

SURGICAL INSTRUMENTS REPRESENT. 4 CLASS

K-Number: K822151 · 1982-08-19

ApplicantRobert I. Chien & Assoc., Inc.
Decision Date1982-08-19
Product CodeHNF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SURGICAL INSTRUMENTS REPRESENT. 4 CLASS 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 1982-08-19 under 510(k) number K822151. The device is classified under product code HNF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL INSTRUMENTS REPRESENT. 4 CLASS?

SURGICAL INSTRUMENTS REPRESENT. 4 CLASS is a medical device that received FDA 510(k) clearance on 1982-08-19. The listed applicant is Robert I. Chien & Assoc., Inc.. The 510(k) number is K822151.

When did SURGICAL INSTRUMENTS REPRESENT. 4 CLASS receive FDA 510(k) clearance?

SURGICAL INSTRUMENTS REPRESENT. 4 CLASS received FDA 510(k) clearance on 1982-08-19, under 510(k) number K822151.

Who is the listed applicant for SURGICAL INSTRUMENTS REPRESENT. 4 CLASS?

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 SURGICAL INSTRUMENTS REPRESENT. 4 CLASS?

The FDA product code for SURGICAL INSTRUMENTS REPRESENT. 4 CLASS is HNF.

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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.

K811632UNSTERILIZED LAPAROTOMY SPONGES (CHINA)K811631THERMOMETER (MADE IN CHINA)K810054RICA (DIAGNOSTIC INSTRUMENTS)K801819SURGICAL INSTRUMENTSK801028RICA OR SMIC SURGICAL INSTRUMENTS

Related Devices (Code: HNF)

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.

K022840STEPHENS DISPOSABLE SCISSORSStephens InstrumentsK897093INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA.Microline Pentax, Inc.K873099MANUAL OPHTHALMIC SURGICAL INSTRUMENTSAlcon LaboratoriesK85176813-550,13-560 WESCOTT SCOSSORS (EYE)ArtiberiaK821290LITTAUER SCISSORS 5 1/2Conphar, Inc.K821286IRIS SCISSORS STRAIGHT 4 1/2Conphar, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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