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FDA 510(k)

R-MED MINI-RETRACTOR

K-Number: K950108 · 1995-05-11

ApplicantR-Med, Inc.
Decision Date1995-05-11
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

R-MED MINI-RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is R-Med, Inc.. It received FDA 510(k) clearance on 1995-05-11 under 510(k) number K950108. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R-MED MINI-RETRACTOR?

R-MED MINI-RETRACTOR is a medical device that received FDA 510(k) clearance on 1995-05-11. The listed applicant is R-Med, Inc.. The 510(k) number is K950108.

When did R-MED MINI-RETRACTOR receive FDA 510(k) clearance?

R-MED MINI-RETRACTOR received FDA 510(k) clearance on 1995-05-11, under 510(k) number K950108.

Who is the listed applicant for R-MED MINI-RETRACTOR?

The FDA 510(k) record lists R-Med, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R-MED MINI-RETRACTOR?

The FDA product code for R-MED MINI-RETRACTOR is HET.

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.

Other records listing R-Med, 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.

View all 9 devices →

Related Devices (Code: HET)

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.

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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