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FDA 510(k)

SYNEVAC VACUUM SOURCE UNIT

K-Number: K831085 · 1983-06-08

ApplicantSynemed, Inc.
Decision Date1983-06-08
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYNEVAC VACUUM SOURCE UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Synemed, Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831085. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNEVAC VACUUM SOURCE UNIT?

SYNEVAC VACUUM SOURCE UNIT is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Synemed, Inc.. The 510(k) number is K831085.

When did SYNEVAC VACUUM SOURCE UNIT receive FDA 510(k) clearance?

SYNEVAC VACUUM SOURCE UNIT received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831085.

Who is the listed applicant for SYNEVAC VACUUM SOURCE UNIT?

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

What is the FDA product code for SYNEVAC VACUUM SOURCE UNIT?

The FDA product code for SYNEVAC VACUUM SOURCE UNIT is BTA.

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Other records listing Synemed, Inc. as applicant

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K954037FIELD TRENDK852936THE FIELDMASTER MODEL 275K833274DERMATOLOGY HANDPIECE-OPHTH LASERK828585OPTHALAS PHOTOCOAGULATORK822853MODEL 200 SQUIDK813282SYNEVAC VACUUM CURETTAGE SYSTEMS

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Related Devices (Code: BTA)

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.

K253629Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)Shenzhen Root Innovation Technology Co., Ltd.K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)Shenzhen Kingboom Technology Co., Ltd.

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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