510(k) K991995
- Device
- SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS
- Applicant
- SOFTCHROME, INC.
- 510(k) number
- K991995
- Product code
- MZD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-08-27
- Date received
- 1999-06-14
- Regulation
- 886.5925
- Classification name
- System, In-office Tinting, Contact Lenses
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARTIN DALSING
- Address
- 623 Glacier Dr. Grand Junction CO US 81503 81503
Source Documents#
Legacy Summary#
summary
FDA Review#
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