The following data is part of a premarket notification filed by Medical Marketing Concepts with the FDA for Anesthesia/respiratory Face Mask.
Device ID | K953107 |
510k Number | K953107 |
Device Name: | ANESTHESIA/RESPIRATORY FACE MASK |
Classification | Mask, Gas, Anesthetic |
Applicant | MEDICAL MARKETING CONCEPTS 20 BREEDEN COURT Hardy, VA 24101 |
Contact | Bob Martin |
Correspondent | Bob Martin MEDICAL MARKETING CONCEPTS 20 BREEDEN COURT Hardy, VA 24101 |
Product Code | BSJ |
CFR Regulation Number | 868.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-03 |
Decision Date | 1995-08-15 |