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FDA 510(k)

SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP

K-Number: K954116 · 1995-11-06

ApplicantTechnical Products, Inc.
Decision Date1995-11-06
Product CodeFEW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP is the device name listed in this FDA 510(k) record. The listed applicant is Technical Products, Inc.. It received FDA 510(k) clearance on 1995-11-06 under 510(k) number K954116. The device is classified under product code FEW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP?

SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP is a medical device that received FDA 510(k) clearance on 1995-11-06. The listed applicant is Technical Products, Inc.. The 510(k) number is K954116.

When did SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP receive FDA 510(k) clearance?

SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP received FDA 510(k) clearance on 1995-11-06, under 510(k) number K954116.

Who is the listed applicant for SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP?

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

What is the FDA product code for SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP?

The FDA product code for SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP is FEW.

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Other records listing Technical 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.

K013321SILICONE TRACHEAL T-TUBESK973385OVAL SHAPESK973166DOW CORNING SILASTIC ELASTOMER Q7-4750K971472SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRAK971613SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING

Related Devices (Code: FEW)

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.

K070879BARD MALECOT AND PEZZER DRAINSC.R. Bard, Inc.K981258MANAN MALECOT BASKET DRAINAGE CATHETERMedical Device Technologies, Inc.K954147MANAN MALECOT BASKET DRAINAGE CATHETERManan Medical Products, Inc.K920423OLYMPIC SMART SCALE CARE CENTEROlympic Medical Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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