The following data is part of a premarket notification filed by Sacks Holdings, Inc. with the FDA for Sacks Holdings Inc.'s Contact Lens Storage Case.
| Device ID | K121030 |
| 510k Number | K121030 |
| Device Name: | SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE |
| Classification | Case, Contact Lens |
| Applicant | SACKS HOLDINGS, INC. P.O. BOX 676211 Rancho Santa Fe, CA 92067 |
| Contact | Devin Chodorow |
| Correspondent | Devin Chodorow SACKS HOLDINGS, INC. P.O. BOX 676211 Rancho Santa Fe, CA 92067 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-05 |
| Decision Date | 2012-07-06 |
| Summary: | summary |