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FDA 510(k)

INAMED RHEMO-D (TM) DILATOR

K-Number: K894618 · 1990-01-18

ApplicantInamed Development Co.
Decision Date1990-01-18
Product CodeFFP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INAMED RHEMO-D (TM) DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Inamed Development Co.. It received FDA 510(k) clearance on 1990-01-18 under 510(k) number K894618. The device is classified under product code FFP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INAMED RHEMO-D (TM) DILATOR?

INAMED RHEMO-D (TM) DILATOR is a medical device that received FDA 510(k) clearance on 1990-01-18. The listed applicant is Inamed Development Co.. The 510(k) number is K894618.

When did INAMED RHEMO-D (TM) DILATOR receive FDA 510(k) clearance?

INAMED RHEMO-D (TM) DILATOR received FDA 510(k) clearance on 1990-01-18, under 510(k) number K894618.

Who is the listed applicant for INAMED RHEMO-D (TM) DILATOR?

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

What is the FDA product code for INAMED RHEMO-D (TM) DILATOR?

The FDA product code for INAMED RHEMO-D (TM) DILATOR is FFP.

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Other records listing Inamed Development 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.

K931548INAMED DEVELOPMENT ASPIRATION TIPK904265INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDERK901764INAMED CONVERTIBLE DRAIN SYSTEMK901742INAMED SMALL DRAIN SYSTEMK896491INAMED CLOSED-WOUND DRAIN SYSTEMK894073INAMED PRO-TEC SILICONE SURGICAL GLOVES

View all 7 devices →

Related Devices (Code: FFP)

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.

K964634ANOKRYOMk Conquest Intl., Inc.K901426COLONIC BALLOON DILATORTelemed Systems, Inc.K884713COLONIC BALLOON DIALATORSPrimrose Medical, Inc.K830354COLORECTAL DILATORCleveland Medical Supply & Services

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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