510(k) K873967
- Device
- SPECTACLE, MAGNIFYING
- Applicant
- SWANK PLUS LTD.
- 510(k) number
- K873967
- Product code
- HOT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-02-26
- Date received
- 1987-09-29
- Regulation
- 886.5910
- Classification name
- Aid, Vision Image Intensification
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CIDER LAI
- Address
- P.O. Box 70750 Kowloon Central Post Office Hong Kong HK
FDA Registration Numbers#
- 3013436538
- 1000261180
- 3003951061
- 3008309602
- 3021892531
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HOT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K863994 | VIEWSCAN | Sensory Aids Corp. | 1986-10-31 |
Legacy Summary#
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FDA Review#
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