MITYVAC

Extractor, Vacuum, Fetal

PRISM TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Prism Technologies, Inc. with the FDA for Mityvac.

Pre-market Notification Details

• Device ID: K980212
• 510k Number: K980212
• Device Name: MITYVAC
• Classification: Extractor, Vacuum, Fetal
• Applicant: PRISM TECHNOLOGIES, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004
• Contact: Howard M Holstein, Esq.
• Correspondent: Howard M Holstein, Esq.; PRISM TECHNOLOGIES, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004
• Product Code: HDB
• CFR Regulation Number: 884.4340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-01-21
• Decision Date: 1998-07-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00888937003147	K980212	000