The following data is part of a premarket notification filed by W.r. Grace & Co.-conn. with the FDA for Medical Adhesive Tape.
Device ID | K860804 |
510k Number | K860804 |
Device Name: | MEDICAL ADHESIVE TAPE |
Classification | Tape And Bandage, Adhesive |
Applicant | W.R. GRACE & CO.-CONN. 55 HAYDEN AVE. Lexington, MA 02173 |
Contact | Robert S Freeman |
Correspondent | Robert S Freeman W.R. GRACE & CO.-CONN. 55 HAYDEN AVE. Lexington, MA 02173 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-04 |
Decision Date | 1986-03-24 |