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FDA 510(k)

PRISMA DISPOSABLE SILICONE BULB

K-Number: K874990 · 1988-04-13

ApplicantAdvanced Surgical Products, Inc.
Decision Date1988-04-13
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PRISMA DISPOSABLE SILICONE BULB is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Products, Inc.. It received FDA 510(k) clearance on 1988-04-13 under 510(k) number K874990. The device is classified under product code HMX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISMA DISPOSABLE SILICONE BULB?

PRISMA DISPOSABLE SILICONE BULB is a medical device that received FDA 510(k) clearance on 1988-04-13. The listed applicant is Advanced Surgical Products, Inc.. The 510(k) number is K874990.

When did PRISMA DISPOSABLE SILICONE BULB receive FDA 510(k) clearance?

PRISMA DISPOSABLE SILICONE BULB received FDA 510(k) clearance on 1988-04-13, under 510(k) number K874990.

Who is the listed applicant for PRISMA DISPOSABLE SILICONE BULB?

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

What is the FDA product code for PRISMA DISPOSABLE SILICONE BULB?

The FDA product code for PRISMA DISPOSABLE SILICONE BULB is HMX.

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Other records listing Advanced Surgical Products, 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.

K030926FAST THROW STAINLESS STEEL SURGICAL SUTUREK895800ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATORK896754I/A HANDPIECEK896305MULTI-USE I/A HANDPIECEK884557ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECEK884556DREYER CURVED ENDOILLUMINATOR

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Related Devices (Code: HMX)

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.

K010305WEISS RETINAL CANNULAMicron Surgical, Inc.K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIESRetinalabs.ComK970873ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)American Medical Devices, Inc.K943932STERISEAL OPHTHALMIC CANNULAPharma-Plast, Ltd.K942403INFUSION CANNULAMicrosurgical Technology, Inc.K934844INTER TIP TMicrosurgical 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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