The following data is part of a premarket notification filed by Greer Laboratories, Inc. with the FDA for Greer Dermapik System.
Device ID | K890360 |
510k Number | K890360 |
Device Name: | GREER DERMAPIK SYSTEM |
Classification | System, Delivery, Allergen And Vaccine |
Applicant | GREER LABORATORIES, INC. P.O. BOX 800 Lenoir, NC 28645 |
Contact | White, Jr. |
Correspondent | White, Jr. GREER LABORATORIES, INC. P.O. BOX 800 Lenoir, NC 28645 |
Product Code | LDH |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-25 |
Decision Date | 1989-06-23 |