The following data is part of a premarket notification filed by Carl Parker Associates, Inc. with the FDA for Compleat Surgical Mask.
Device ID | K962654 |
510k Number | K962654 |
Device Name: | COMPLEAT SURGICAL MASK |
Classification | Mask, Surgical |
Applicant | CARL PARKER ASSOCIATES, INC. 275 OSER AVE. Hauppauge, NY 11788 |
Contact | Andrew Parker |
Correspondent | Andrew Parker CARL PARKER ASSOCIATES, INC. 275 OSER AVE. Hauppauge, NY 11788 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-08 |
Decision Date | 1997-01-27 |
Summary: | summary |