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FDA 510(k)

VILLALTA RETRACTOR

K-Number: K943875 · 1994-11-09

ApplicantHct, Inc.
Decision Date1994-11-09
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VILLALTA RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Hct, Inc.. It received FDA 510(k) clearance on 1994-11-09 under 510(k) number K943875. 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 VILLALTA RETRACTOR?

VILLALTA RETRACTOR is a medical device that received FDA 510(k) clearance on 1994-11-09. The listed applicant is Hct, Inc.. The 510(k) number is K943875.

When did VILLALTA RETRACTOR receive FDA 510(k) clearance?

VILLALTA RETRACTOR received FDA 510(k) clearance on 1994-11-09, under 510(k) number K943875.

Who is the listed applicant for VILLALTA RETRACTOR?

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

What is the FDA product code for VILLALTA RETRACTOR?

The FDA product code for VILLALTA RETRACTOR is GAD.

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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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