The following data is part of a premarket notification filed by Cilco, Inc. with the FDA for Cilco Diamond Knives & Diamond Knife Linear Gauge.
Device ID | K861334 |
510k Number | K861334 |
Device Name: | CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE |
Classification | Knife, Ophthalmic |
Applicant | CILCO, INC. P.O. BOX 2865, 2865 POMONA BLVD. Pomona, CA 91768 |
Contact | Molinaro, Jr. |
Correspondent | Molinaro, Jr. CILCO, INC. P.O. BOX 2865, 2865 POMONA BLVD. Pomona, CA 91768 |
Product Code | HNN |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-09 |
Decision Date | 1986-05-02 |