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FDA 510(k)

ENSWELL

K-Number: K831899 · 1983-07-07

ApplicantDr. Micheal A. Sabia
Decision Date1983-07-07
Product CodeIME
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ENSWELL is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Micheal A. Sabia. It received FDA 510(k) clearance on 1983-07-07 under 510(k) number K831899. The device is classified under product code IME. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENSWELL?

ENSWELL is a medical device that received FDA 510(k) clearance on 1983-07-07. The listed applicant is Dr. Micheal A. Sabia. The 510(k) number is K831899.

When did ENSWELL receive FDA 510(k) clearance?

ENSWELL received FDA 510(k) clearance on 1983-07-07, under 510(k) number K831899.

Who is the listed applicant for ENSWELL?

The FDA 510(k) record lists Dr. Micheal A. Sabia as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENSWELL?

The FDA product code for ENSWELL is IME.

Related Clinical Trials

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.

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Other records listing Dr. Micheal A. Sabia 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.

K831898SCOLIMETER

Related Devices (Code: IME)

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.

K923627COLD PACKFriendmed ProductsK915876HOTPADTen Comfort Corp.K921446HOT OR COLD PACK (THERMIPAQ)Thermionics Corp.K905207MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESSMicro Surgical Instruments Corp.K882413SUBOCCIPITAL ICE PILLOWFerguson MedicalK863654RE-HEATER, HOT PACKK & L Ent.

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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