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FDA 510(k)

STERILE SUTURE REMOVAL KIT

K-Number: K771448 · 1977-09-06

ApplicantPremium Plastics, Inc.
Decision Date1977-09-06
Product CodeKDD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE SUTURE REMOVAL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Premium Plastics, Inc.. It received FDA 510(k) clearance on 1977-09-06 under 510(k) number K771448. The device is classified under product code KDD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE SUTURE REMOVAL KIT?

STERILE SUTURE REMOVAL KIT is a medical device that received FDA 510(k) clearance on 1977-09-06. The listed applicant is Premium Plastics, Inc.. The 510(k) number is K771448.

When did STERILE SUTURE REMOVAL KIT receive FDA 510(k) clearance?

STERILE SUTURE REMOVAL KIT received FDA 510(k) clearance on 1977-09-06, under 510(k) number K771448.

Who is the listed applicant for STERILE SUTURE REMOVAL KIT?

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

What is the FDA product code for STERILE SUTURE REMOVAL KIT?

The FDA product code for STERILE SUTURE REMOVAL KIT is KDD.

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.

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Other records listing Premium Plastics, 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.

K953226PULM O2 SUCTION CATHETER TRAYSK950851GENT-L-KARE TRACHEOSTOMY TRAYSK950850GENT-L-KARE LACERATION TRAYSK943740ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)K890107GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KITK893135GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER

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Related Devices (Code: KDD)

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.

K072814CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURESCovidienK011514INSTRUMENTS FOR ONE TIME USE - DISPOSABLEKencap , Ltd.K971317NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYSNational Healthcare Mfg. Corp.K960456DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAYDenver Biomaterials, Inc.K936255CUSTOM CV PACKAssociated MedicalK932219SUTURE SET OR LACERATION TRAYS (PACKS)Associated Medical Products Co.

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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