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FDA 510(k)

S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)

K-Number: K960640 · 1997-02-14

Decision Date1997-02-14
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh. It received FDA 510(k) clearance on 1997-02-14 under 510(k) number K960640. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)?

S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1997-02-14. The listed applicant is Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh. The 510(k) number is K960640.

When did S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) receive FDA 510(k) clearance?

S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) received FDA 510(k) clearance on 1997-02-14, under 510(k) number K960640.

Who is the listed applicant for S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)?

The FDA 510(k) record lists Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)?

The FDA product code for S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) is HET.

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.

Other records listing Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh 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.

View all 9 devices →

Related Devices (Code: HET)

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.

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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