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FDA 510(k)

DEKNA BAND KIT

K-Number: K862115 · 1986-08-19

ApplicantDeknatel, Inc.
Decision Date1986-08-19
Product CodeITG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DEKNA BAND KIT is the device name listed in this FDA 510(k) record. The listed applicant is Deknatel, Inc.. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K862115. The device is classified under product code ITG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEKNA BAND KIT?

DEKNA BAND KIT is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Deknatel, Inc.. The 510(k) number is K862115.

When did DEKNA BAND KIT receive FDA 510(k) clearance?

DEKNA BAND KIT received FDA 510(k) clearance on 1986-08-19, under 510(k) number K862115.

Who is the listed applicant for DEKNA BAND KIT?

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

What is the FDA product code for DEKNA BAND KIT?

The FDA product code for DEKNA BAND KIT is ITG.

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Other records listing Deknatel, 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.

K963850PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEMK962683SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATORK964070DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAGK963098PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)K962856PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTRK925243DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER

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Related Devices (Code: ITG)

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.

K873111CONFORMA(TM) PLASTER BANDAGESThe Kendal Co.K842573T.P.G. CAST TAPEThe Poly Group, Inc.K840416HEXCELITEHexcel MedicalK833732NON WETTING UNDERCAST PADDINGAmerican Medical Disposable, Inc.K832992SOFFBAN ORTHOPEDIC PADDINGSmith & Nephew, Inc.K832237ORTHOPEDIC CASTING TAPE MAXCASTCutter Laboratories, 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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