The following data is part of a premarket notification filed by Medical Device Inspection Co., Inc. with the FDA for Mucous Specimen Trap.
| Device ID | K913643 |
| 510k Number | K913643 |
| Device Name: | MUCOUS SPECIMEN TRAP |
| Classification | Trap, Sterile Specimen |
| Applicant | MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Kotula Cook |
| Correspondent | Kotula Cook MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | BYZ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-14 |
| Decision Date | 1991-10-10 |