The following data is part of a premarket notification filed by Ultracell Medical Technologies, Inc. with the FDA for Surgical Spears.
Device ID | K923922 |
510k Number | K923922 |
Device Name: | SURGICAL SPEARS |
Classification | Sponge, Ophthalmic |
Applicant | ULTRACELL MEDICAL TECHNOLOGIES, INC. P.O. BOX 326 North Stonington, CT 06359 |
Contact | George P Korteweg |
Correspondent | George P Korteweg ULTRACELL MEDICAL TECHNOLOGIES, INC. P.O. BOX 326 North Stonington, CT 06359 |
Product Code | HOZ |
CFR Regulation Number | 886.4790 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-05 |
Decision Date | 1993-03-19 |