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FDA 510(k)

MASTERHINGE

K-Number: K833084 · 1983-10-14

ApplicantMark One Healthcare Products
Decision Date1983-10-14
Product CodeLGF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MASTERHINGE is the device name listed in this FDA 510(k) record. The listed applicant is Mark One Healthcare Products. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K833084. The device is classified under product code LGF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASTERHINGE?

MASTERHINGE is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Mark One Healthcare Products. The 510(k) number is K833084.

When did MASTERHINGE receive FDA 510(k) clearance?

MASTERHINGE received FDA 510(k) clearance on 1983-10-14, under 510(k) number K833084.

Who is the listed applicant for MASTERHINGE?

The FDA 510(k) record lists Mark One Healthcare Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MASTERHINGE?

The FDA product code for MASTERHINGE is LGF.

Related Clinical Trials

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Other records listing Mark One Healthcare Products 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.

K891986MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCEK833867PAREMA K BAND NON-STERILEK770396DRAPES, MODESTYK761268SKIN PRESSURE PROTECTORS

Related Devices (Code: LGF)

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.

K043526SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATICNoble Fiber Technologies, Inc.K973420CLINITEX CAST PADDINGClinitex Medical Corp.K973417CLINITEX STOCKINETTEClinitex Medical Corp.K955320PROTEC COTTON PADDING BANDAGEDerivadas Degasa S.A. DE C.V.K932507QUICK-CAST IMMOBILIZERLandec Corp.K931672CARAPACE STERILE CAST PADDINGCarapace, 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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