510(k) K883839
- Device
- ND:YAG LASER SPECTACLES, MST MODEL #YLS-5
- Applicant
- MARLO SURGICAL TECHNOLOGY
- 510(k) number
- K883839
- Product code
- KYP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-12-09
- Date received
- 1988-09-12
- Regulation
- 880.5740
- Classification name
- Snake Bite Suction Kit
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SCOTT C MARLOW
- Address
- 1810 Joseph Lloyd Pkwy. Willoughby OH US 44094 44094
FDA Registration Numbers#
- 1061124
- 3007701666
- 3017417635
- 3004111573
- 3007187674
- 3015529379
- 1025972
- 3015495690
- 1643817
- 3007329020
- 3009888344
- 1423537
- 3008808082
- 9616088
- 2082653
- 3023917
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KYP #
Legacy Summary#
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FDA Review#
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