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FDA 510(k)

SUN-LITE BLUE SLIT

K-Number: K840492 · 1984-05-09

ApplicantSuncoast Medical Manufacturers, Inc.
Decision Date1984-05-09
Product CodeHTP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUN-LITE BLUE SLIT is the device name listed in this FDA 510(k) record. The listed applicant is Suncoast Medical Manufacturers, Inc.. It received FDA 510(k) clearance on 1984-05-09 under 510(k) number K840492. The device is classified under product code HTP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUN-LITE BLUE SLIT?

SUN-LITE BLUE SLIT is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Suncoast Medical Manufacturers, Inc.. The 510(k) number is K840492.

When did SUN-LITE BLUE SLIT receive FDA 510(k) clearance?

SUN-LITE BLUE SLIT received FDA 510(k) clearance on 1984-05-09, under 510(k) number K840492.

Who is the listed applicant for SUN-LITE BLUE SLIT?

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

What is the FDA product code for SUN-LITE BLUE SLIT?

The FDA product code for SUN-LITE BLUE SLIT is HTP.

Other records listing Suncoast Medical Manufacturers, 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.

K841604ADJUST-A-TEMP HIGH TEMPERATUREK841509REPLACE-A-TIP ADJUSTABLE HIGH TEMP.K841603ADJUST-A-TEMP MICROK841459REPLACE-A-TIP ADJUST. LOW TEMP.-K841591PYRO-TIPK840376SURG-A STAT LOOP TIP

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Related Devices (Code: HTP)

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.

K931733INTERMEDICS ORTHOPEDICS REAMERSIntermedics OrthopedicsK870842SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASPWarsaw Orthopedic, Inc.K862659CONCEPT ARTHROSCOPY RASPConcept, Inc.K8419814MM & 5MM FILEStainless Mfg., 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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