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FDA 510(k)

APOLLO STERILE BLADES

K-Number: K852661 · 1985-07-11

ApplicantOrthofab, Inc.
Decision Date1985-07-11
Product CodeGES
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

APOLLO STERILE BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Orthofab, Inc.. It received FDA 510(k) clearance on 1985-07-11 under 510(k) number K852661. The device is classified under product code GES. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APOLLO STERILE BLADES?

APOLLO STERILE BLADES is a medical device that received FDA 510(k) clearance on 1985-07-11. The listed applicant is Orthofab, Inc.. The 510(k) number is K852661.

When did APOLLO STERILE BLADES receive FDA 510(k) clearance?

APOLLO STERILE BLADES received FDA 510(k) clearance on 1985-07-11, under 510(k) number K852661.

Who is the listed applicant for APOLLO STERILE BLADES?

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

What is the FDA product code for APOLLO STERILE BLADES?

The FDA product code for APOLLO STERILE BLADES is GES.

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Other records listing Orthofab, 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.

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Related Devices (Code: GES)

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.

K032242PERSONNA PLUS SAFETY SCALPEL SYSTEMOmi Manufacturing Pty., Ltd.K932998EASY-ONDevon Industries, Inc.K923170LOS ALAMOS RETRACTABLE KNIFEInnovative Surgical Technology, Inc.K915119SCALPEL BLADE REMOVER (BLADEGARD)Intergrated Visual, Inc.K911913PRECISION GLIDE - ENHANCED SURGICAL BLADEBd Becton Dickinson Vacutainer Systems PreanalyticK900266STERILE CARBON STEEL SURGICAL BLADERahn Laboratories

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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