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FDA 510(k)

PREMIO

K-Number: K060465 · 2007-01-17

ApplicantPeters Surgical
Decision Date2007-01-17
Product CodeMXW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PREMIO is the device name listed in this FDA 510(k) record. The listed applicant is Peters Surgical. It received FDA 510(k) clearance on 2007-01-17 under 510(k) number K060465. The device is classified under product code MXW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIO?

PREMIO is a medical device that received FDA 510(k) clearance on 2007-01-17. The listed applicant is Peters Surgical. The 510(k) number is K060465.

When did PREMIO receive FDA 510(k) clearance?

PREMIO received FDA 510(k) clearance on 2007-01-17, under 510(k) number K060465.

Who is the listed applicant for PREMIO?

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

What is the FDA product code for PREMIO?

The FDA product code for PREMIO is MXW.

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Other records listing Peters Surgical 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.

K233265Monotime and Optime RK232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)K071281UNIRING - ANNULOPLASTY RING WITH SIZERSK060163CARDIOFLON, CARDIOXYLK062366OPTIME, SINUSORB PGAK052701COROLENE

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Related Devices (Code: MXW)

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.

K052953NUVANCE* FACIAL REJUVENATION SYSTEMETHICON, 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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