The following data is part of a premarket notification filed by Western Medical Products, Inc. with the FDA for Soft Lens Folding Block.
Device ID | K891487 |
510k Number | K891487 |
Device Name: | SOFT LENS FOLDING BLOCK |
Classification | Forceps, Ophthalmic |
Applicant | WESTERN MEDICAL PRODUCTS, INC. 11211 SORRENTO VALLEY ROAD, SUITE X San Diego, CA 92121 |
Contact | Richard T Swanson |
Correspondent | Richard T Swanson WESTERN MEDICAL PRODUCTS, INC. 11211 SORRENTO VALLEY ROAD, SUITE X San Diego, CA 92121 |
Product Code | HNR |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-17 |
Decision Date | 1989-08-15 |