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FDA 510(k)

OMNISURG SIDE MOUNTING CLAMP & RAIL EXT.

K-Number: K821933 · 1982-07-08

ApplicantPolamedco, Inc.
Decision Date1982-07-08
Product CodeFWZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNISURG SIDE MOUNTING CLAMP & RAIL EXT. is the device name listed in this FDA 510(k) record. The listed applicant is Polamedco, Inc.. It received FDA 510(k) clearance on 1982-07-08 under 510(k) number K821933. The device is classified under product code FWZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNISURG SIDE MOUNTING CLAMP & RAIL EXT.?

OMNISURG SIDE MOUNTING CLAMP & RAIL EXT. is a medical device that received FDA 510(k) clearance on 1982-07-08. The listed applicant is Polamedco, Inc.. The 510(k) number is K821933.

When did OMNISURG SIDE MOUNTING CLAMP & RAIL EXT. receive FDA 510(k) clearance?

OMNISURG SIDE MOUNTING CLAMP & RAIL EXT. received FDA 510(k) clearance on 1982-07-08, under 510(k) number K821933.

Who is the listed applicant for OMNISURG SIDE MOUNTING CLAMP & RAIL EXT.?

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

What is the FDA product code for OMNISURG SIDE MOUNTING CLAMP & RAIL EXT.?

The FDA product code for OMNISURG SIDE MOUNTING CLAMP & RAIL EXT. is FWZ.

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Other records listing Polamedco, 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: FWZ)

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.

K960019RETRACTOR ARM CLAMPBiopsys Medical, Inc.K945415'LIL MAC ACCESSORY CLAMP(TM)D.L. Nelson and Assoc., Inc.K944779CARBON LIGHTS HAND SURGERY TABLEAllen Medical Systems, Inc.K935381KAPS POSITIONING ARMAndronic Devices, Ltd.K931037WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)Whitmore Ent., Inc.K926225SPONGE COUNTERAmerican Medical Manufacturer, 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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