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FDA 510(k)

AMER. SURGICAL CORP. EXTRA PLUS PAK

K-Number: K841738 · 1984-10-05

ApplicantAmerican Surgical Co., Inc.
Decision Date1984-10-05
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AMER. SURGICAL CORP. EXTRA PLUS PAK is the device name listed in this FDA 510(k) record. The listed applicant is American Surgical Co., Inc.. It received FDA 510(k) clearance on 1984-10-05 under 510(k) number K841738. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMER. SURGICAL CORP. EXTRA PLUS PAK?

AMER. SURGICAL CORP. EXTRA PLUS PAK is a medical device that received FDA 510(k) clearance on 1984-10-05. The listed applicant is American Surgical Co., Inc.. The 510(k) number is K841738.

When did AMER. SURGICAL CORP. EXTRA PLUS PAK receive FDA 510(k) clearance?

AMER. SURGICAL CORP. EXTRA PLUS PAK received FDA 510(k) clearance on 1984-10-05, under 510(k) number K841738.

Who is the listed applicant for AMER. SURGICAL CORP. EXTRA PLUS PAK?

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

What is the FDA product code for AMER. SURGICAL CORP. EXTRA PLUS PAK?

The FDA product code for AMER. SURGICAL CORP. EXTRA PLUS PAK is HQE.

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 American Surgical Co., 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.

K834160VITREONIC PLUSK834162VIT PACK834158EXTRA SENSORY PLUSK834163ULTRAVITK833697EXTRA SENSORY PAK-DISPOS. ACCESSK833617EXTRA PLUS TM

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Related Devices (Code: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, 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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