The following data is part of a premarket notification filed by S. Jackson, Inc. with the FDA for Nylamid Mesh Pad Full & Half.
Device ID | K852011 |
510k Number | K852011 |
Device Name: | NYLAMID MESH PAD FULL & HALF |
Classification | Mesh, Surgical |
Applicant | S. JACKSON, INC. 15 ROTH ST. P.O. BOX 4487 Alexandria, VA 22303 |
Contact | Jackson |
Correspondent | Jackson S. JACKSON, INC. 15 ROTH ST. P.O. BOX 4487 Alexandria, VA 22303 |
Product Code | FTM |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-26 |
Decision Date | 1985-06-11 |