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FDA 510(k)

VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363

K-Number: K861858 · 1986-07-31

ApplicantPeritone Research, Ltd.
Decision Date1986-07-31
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363 is the device name listed in this FDA 510(k) record. The listed applicant is Peritone Research, Ltd.. It received FDA 510(k) clearance on 1986-07-31 under 510(k) number K861858. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363?

VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363 is a medical device that received FDA 510(k) clearance on 1986-07-31. The listed applicant is Peritone Research, Ltd.. The 510(k) number is K861858.

When did VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363 receive FDA 510(k) clearance?

VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363 received FDA 510(k) clearance on 1986-07-31, under 510(k) number K861858.

Who is the listed applicant for VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363?

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

What is the FDA product code for VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363?

The FDA product code for VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363 is HIR.

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Other records listing Peritone Research, Ltd. 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.

K861683MONSANTO SANTOPRENE (PERITONE DEVICE)

Related Devices (Code: HIR)

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.

K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd.K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc.K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc.K231780Perifit Care+X6 InnovationsK221476PerifitX6 Innovations

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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