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FDA 510(k)

HARGIS SR2 SELF-RETRACTION SYSTEM

K-Number: K921017 · 1993-07-02

ApplicantMedin Corp.
Decision Date1993-07-02
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HARGIS SR2 SELF-RETRACTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medin Corp.. It received FDA 510(k) clearance on 1993-07-02 under 510(k) number K921017. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARGIS SR2 SELF-RETRACTION SYSTEM?

HARGIS SR2 SELF-RETRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 1993-07-02. The listed applicant is Medin Corp.. The 510(k) number is K921017.

When did HARGIS SR2 SELF-RETRACTION SYSTEM receive FDA 510(k) clearance?

HARGIS SR2 SELF-RETRACTION SYSTEM received FDA 510(k) clearance on 1993-07-02, under 510(k) number K921017.

Who is the listed applicant for HARGIS SR2 SELF-RETRACTION SYSTEM?

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

What is the FDA product code for HARGIS SR2 SELF-RETRACTION SYSTEM?

The FDA product code for HARGIS SR2 SELF-RETRACTION SYSTEM is GAD.

Related Clinical Trials

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Other records listing Medin 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.

K921020HARGIS SELF RETRACTION SYSTEMK921019HARGIS RECTAL SELF RETRATION SYSTEMK833343STERILIZATION CONTAINERK761032CRADLING SYSTEM

Related Devices (Code: GAD)

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.

K152538JRP Wound SpreaderJ.R. Parker, LLCK151104OTELO LLSpineartK132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.K071775DASHEzsurgicalK050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApple Medical Corp.K043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek

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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