510(k) K131672
- Device
- MICROCYN SCAR MANAGEMENT HYDROGEL
- Applicant
- OCULUS INNOVATIVE SCIENCES
- 510(k) number
- K131672
- Product code
- PFP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-11-15
- Date received
- 2013-06-06
- Regulation
- 878.4025
- Classification name
- Silicone Hydrogel For Scar Management
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRIAN W MARTIN
- Address
- 1129 N. Mcdowell Blvd. Petaluma CA US 94954 94954
FDA Registration Numbers#
- 3015218512
- 3035786168
- 3035783442
- 3012818008
- 3015172365
- 3012852163
- 3007145088
- 3015335956
- 3021332749
- 9681544
- 3022596459
- 3021630959
- 3016615875
- 3023855650
- 3023339256
- 3043026391
- 1000512200
- 3013530901
- 3009655869
- 3012084379
- 3004869142
- 3021389253
- 3042277868
- 3016585381
- 3036035308
- 3030226294
- 3015058854
- 3010713600
- 3007244484
- 3010370474
- 3011529314
- 3004633971
- 3008808560
- 3015264433
- 8022978
- 1825527
- 3015991056
- 3004554409
- 3010018659
Source Documents#
Legacy Summary#
summary
FDA Review#
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