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FDA 510(k)

UPDATED STERILE PROCEDURAL KIT

K-Number: K863632 · 1986-09-29

ApplicantBiological & Environmental Control Laboratories
Decision Date1986-09-29
Product Code
DecisionSubstantially Equivalent

Device Summary

UPDATED STERILE PROCEDURAL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biological & Environmental Control Laboratories. It received FDA 510(k) clearance on 1986-09-29 under 510(k) number K863632. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UPDATED STERILE PROCEDURAL KIT?

UPDATED STERILE PROCEDURAL KIT is a medical device that received FDA 510(k) clearance on 1986-09-29. The listed applicant is Biological & Environmental Control Laboratories. The 510(k) number is K863632.

When did UPDATED STERILE PROCEDURAL KIT receive FDA 510(k) clearance?

UPDATED STERILE PROCEDURAL KIT received FDA 510(k) clearance on 1986-09-29, under 510(k) number K863632.

Who is the listed applicant for UPDATED STERILE PROCEDURAL KIT?

The FDA 510(k) record lists Biological & Environmental Control Laboratories as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Biological & Environmental Control Laboratories 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.

K971500ACCESS SYSTEMS NEEDLELESS VIAL ADAPTERK962801SAFE MATE I.V. EXTENSION SETSK962802SAFE MATE I.V. FLUID DELIVERY SETSK961328BEC SHROUDED PLASTIC CANNULAK961327BEC NEEDLELESS INJECTION SITEK863635UPDATED STERILE ENDOTRACHEAL BRUSHES

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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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