The following data is part of a premarket notification filed by Spoma Intl. Corp. with the FDA for Spoma International Corporation.
| Device ID | K943352 |
| 510k Number | K943352 |
| Device Name: | SPOMA INTERNATIONAL CORPORATION |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | SPOMA INTL. CORP. 2729 S. PEPPERDALE DR. Rowland Heights, CA 91748 |
| Contact | Jennifer Kuo |
| Correspondent | Jennifer Kuo SPOMA INTL. CORP. 2729 S. PEPPERDALE DR. Rowland Heights, CA 91748 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-12 |
| Decision Date | 1994-08-05 |