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FDA 510(k)

QCR SYSTEM I AND QCR SYSTEM II

K-Number: K893380 · 1989-11-16

ApplicantBremer Mfg. & Tool Co., Inc.
Decision Date1989-11-16
Product CodeLGH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

QCR SYSTEM I AND QCR SYSTEM II is the device name listed in this FDA 510(k) record. The listed applicant is Bremer Mfg. & Tool Co., Inc.. It received FDA 510(k) clearance on 1989-11-16 under 510(k) number K893380. The device is classified under product code LGH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QCR SYSTEM I AND QCR SYSTEM II?

QCR SYSTEM I AND QCR SYSTEM II is a medical device that received FDA 510(k) clearance on 1989-11-16. The listed applicant is Bremer Mfg. & Tool Co., Inc.. The 510(k) number is K893380.

When did QCR SYSTEM I AND QCR SYSTEM II receive FDA 510(k) clearance?

QCR SYSTEM I AND QCR SYSTEM II received FDA 510(k) clearance on 1989-11-16, under 510(k) number K893380.

Who is the listed applicant for QCR SYSTEM I AND QCR SYSTEM II?

The FDA 510(k) record lists Bremer Mfg. & Tool Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QCR SYSTEM I AND QCR SYSTEM II?

The FDA product code for QCR SYSTEM I AND QCR SYSTEM II is LGH.

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Related Devices (Code: LGH)

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.

K932653SWISSTEK 2000(TM) CAST REMOVAL SYSTEMCarapace, Inc.K901677CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTERBuckman Co., Inc.K895861DELTA-TECH(TM) CAST REMOVAL SYSTEMJohnson & Johnson Professionals, Inc.K873723PLASTER VACUUM, 230V MODEL NO. 4183-161Martin MedicalK873721PLASTER VACUUM, 115V MODEL NO. 4183-160Martin MedicalK873720CAST CUTTER, 230V MODEL NO. 4183-107Martin Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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