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FDA 510(k)

CERVICAL SPATULA

K-Number: K811548 · 1981-06-23

ApplicantProcedure Products, Inc.
Decision Date1981-06-23
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CERVICAL SPATULA is the device name listed in this FDA 510(k) record. The listed applicant is Procedure Products, Inc.. It received FDA 510(k) clearance on 1981-06-23 under 510(k) number K811548. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERVICAL SPATULA?

CERVICAL SPATULA is a medical device that received FDA 510(k) clearance on 1981-06-23. The listed applicant is Procedure Products, Inc.. The 510(k) number is K811548.

When did CERVICAL SPATULA receive FDA 510(k) clearance?

CERVICAL SPATULA received FDA 510(k) clearance on 1981-06-23, under 510(k) number K811548.

Who is the listed applicant for CERVICAL SPATULA?

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

What is the FDA product code for CERVICAL SPATULA?

The FDA product code for CERVICAL SPATULA is HHT.

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Other records listing Procedure Products, Inc. as applicant

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Related Devices (Code: HHT)

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.

K182049exCellerator Cervical Collection DeviceExcell Company, LLCK153128Kolplast Cervical Sample Collection KitKolplast CI SAK111681HISTOBRUSHPuritan Medical Products Company, LLCK083012PAPCONEOtto Bock Pur Life Science GmbHK081522BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGYBio Nuclear Diagnostics, Inc.K072381SOFTPAP CERVICAL CELL COLLECTORCytocore, 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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