510(k) K905722
- Device
- SUTURE APPLIER DEVICE
- Applicant
- LAPAROMED CORP.
- 510(k) number
- K905722
- Product code
- MFJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-03-14
- Date received
- 1990-12-20
- Regulation
- 876.1500
- Classification name
- Device, Endoscopic Suturing
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL LUBOCK
- Address
- 9272 Jeronimo Rd., Unit 109 Irvine CA US 92718 92718
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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