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FDA 510(k)

ASPACH 65,000 (MODIFICATION)

K-Number: K955084 · 1996-01-17

ApplicantThe Anspach Effort, Inc.
Decision Date1996-01-17
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ASPACH 65,000 (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is The Anspach Effort, Inc.. It received FDA 510(k) clearance on 1996-01-17 under 510(k) number K955084. The device is classified under product code HSZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPACH 65,000 (MODIFICATION)?

ASPACH 65,000 (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-01-17. The listed applicant is The Anspach Effort, Inc.. The 510(k) number is K955084.

When did ASPACH 65,000 (MODIFICATION) receive FDA 510(k) clearance?

ASPACH 65,000 (MODIFICATION) received FDA 510(k) clearance on 1996-01-17, under 510(k) number K955084.

Who is the listed applicant for ASPACH 65,000 (MODIFICATION)?

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

What is the FDA product code for ASPACH 65,000 (MODIFICATION)?

The FDA product code for ASPACH 65,000 (MODIFICATION) is HSZ.

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Other records listing The Anspach Effort, 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.

K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)K183545Anspach Helix Dissection ToolsK180063OCM-G1 AttachmentK131053ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEMK113476ANSPACH DISSECTION TOOLSK082637CRANIAL PERFORATOR

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Related Devices (Code: HSZ)

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.

K991588EMS SWISS ORTHOCLAST(Ems Sa) Electro Medical SystemsK972860CURVTEK TSR SYSTEMBiolectron, Inc.K970345ALIGNMENT INSTRUMENTRichard Wolf Medical Instruments Corp.K954080SODEM HIGH SPEED SYSTEMSodem Diffusion SAK944590ETHICON DRILL BIT AND DRILL GUIDEETHICON, Inc.K934336SPINALPLANESynvasive Technology, Inc.

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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