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FDA 510(k)

BIRCOLL BALLOON DISSECTOR

K-Number: K984448 · 1999-01-28

ApplicantWells Johnson Co.
Decision Date1999-01-28
Product CodeFZW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIRCOLL BALLOON DISSECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Wells Johnson Co.. It received FDA 510(k) clearance on 1999-01-28 under 510(k) number K984448. The device is classified under product code FZW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIRCOLL BALLOON DISSECTOR?

BIRCOLL BALLOON DISSECTOR is a medical device that received FDA 510(k) clearance on 1999-01-28. The listed applicant is Wells Johnson Co.. The 510(k) number is K984448.

When did BIRCOLL BALLOON DISSECTOR receive FDA 510(k) clearance?

BIRCOLL BALLOON DISSECTOR received FDA 510(k) clearance on 1999-01-28, under 510(k) number K984448.

Who is the listed applicant for BIRCOLL BALLOON DISSECTOR?

The FDA 510(k) record lists Wells Johnson Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIRCOLL BALLOON DISSECTOR?

The FDA product code for BIRCOLL BALLOON DISSECTOR is FZW.

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Other records listing Wells Johnson Co. 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.

K991437WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00K971580UAS ULTRASONIC ASPIRATOR SYSTEMK945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTK945500WELLS JOHNSON FIXATION SYSTEMK951519WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTK945877WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT

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Related Devices (Code: FZW)

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.

K080158LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEMLb Medical LLCK972109SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDERGeneral Surgical InnovationsK936186AESCULAP SKIN GRAFT MESHERAesculap, Inc.K904265INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDERInamed Development Co.K902349SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDERSurgitekK883303MENTOR RAPID-SPAN (TM) TISSUE EXPANDERMentor Corp.

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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