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FDA 510(k)

DISPOSABLE SURGICAL HEAD SUPPORT

K-Number: K801382 · 1980-06-26

ApplicantInnovative Surgical Products, Inc.
Decision Date1980-06-26
Product CodeFSE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SURGICAL HEAD SUPPORT is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Surgical Products, Inc.. It received FDA 510(k) clearance on 1980-06-26 under 510(k) number K801382. The device is classified under product code FSE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE SURGICAL HEAD SUPPORT?

DISPOSABLE SURGICAL HEAD SUPPORT is a medical device that received FDA 510(k) clearance on 1980-06-26. The listed applicant is Innovative Surgical Products, Inc.. The 510(k) number is K801382.

When did DISPOSABLE SURGICAL HEAD SUPPORT receive FDA 510(k) clearance?

DISPOSABLE SURGICAL HEAD SUPPORT received FDA 510(k) clearance on 1980-06-26, under 510(k) number K801382.

Who is the listed applicant for DISPOSABLE SURGICAL HEAD SUPPORT?

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

What is the FDA product code for DISPOSABLE SURGICAL HEAD SUPPORT?

The FDA product code for DISPOSABLE SURGICAL HEAD SUPPORT is FSE.

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Other records listing Innovative Surgical Products, 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.

K843041HESLIN DISPOS. TUBING SETK840693DISPOSABLE SCLERAL GLOBE PLUGK840695PHACOEMULSIFICATION KITSK840694LENS INSERTION GLIDEK841072IRRIGATION, ASPIRATION TUBING SETSK832235DISPOSABLE VITRECTOMY HANDPIECE

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Related Devices (Code: FSE)

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.

K860503THE POREX RETRACTOR TABLEPorex MedicalK843801MASON EQUIPMENT ORGANIZER & ASPENAspen Laboratories, Inc.K840027OPERATING ROOM STANDHealthmate, Inc.K831042CHEMONUCLEOLYSIS TABLE EXTENSIONOrthopedic Systems, Inc.K830339IMSI/METRIPOND HAND OPERATING TABLEIntl. Management Services, Inc.K822427SELF-CONTAINED MOBILE OPHTHAL. OPER. .Surgi-Quip Inc.U

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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