The following data is part of a premarket notification filed by Apex Medical Technologies, Inc. with the FDA for Apex Specimen Bag.
| Device ID | K930313 |
| 510k Number | K930313 |
| Device Name: | APEX SPECIMEN BAG |
| Classification | Device, Specimen Collection |
| Applicant | APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 San Diego, CA 92121 |
| Contact | Stefanie Kramer |
| Correspondent | Stefanie Kramer APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 San Diego, CA 92121 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-22 |
| Decision Date | 1993-03-18 |