The following data is part of a premarket notification filed by Surgipro Central, Inc. with the FDA for Various Non-sterile Custom Trays/kits.
Device ID | K924690 |
510k Number | K924690 |
Device Name: | VARIOUS NON-STERILE CUSTOM TRAYS/KITS |
Classification | Wound Dressing Kit |
Applicant | SURGIPRO CENTRAL, INC. C/O PAT LAMB & ASSOCIATES P.O. BOX 431 Tarpon Springs, FL 34689 |
Contact | Patrick J Lamb |
Correspondent | Patrick J Lamb SURGIPRO CENTRAL, INC. C/O PAT LAMB & ASSOCIATES P.O. BOX 431 Tarpon Springs, FL 34689 |
Product Code | MCY |
CFR Regulation Number | 880.5075 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-17 |
Decision Date | 1993-07-16 |