The following data is part of a premarket notification filed by American Medical Development, Inc. with the FDA for Sniff Position Pillow.
Device ID | K934235 |
510k Number | K934235 |
Device Name: | SNIFF POSITION PILLOW |
Classification | Support, Patient Position |
Applicant | AMERICAN MEDICAL DEVELOPMENT, INC. 220 COMMERCIAL ST. Boston, MA 02109 |
Contact | Mark Vander Werf |
Correspondent | Mark Vander Werf AMERICAN MEDICAL DEVELOPMENT, INC. 220 COMMERCIAL ST. Boston, MA 02109 |
Product Code | CCX |
CFR Regulation Number | 868.6820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-30 |
Decision Date | 1993-10-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SNIFF POSITION PILLOW 77534115 not registered Dead/Abandoned |
Michael Popitz, MD 2008-07-29 |