The following data is part of a premarket notification filed by Klein-baker Medical, Inc. with the FDA for Neo-care Lumber Puncture Kit.
| Device ID | K970997 |
| 510k Number | K970997 |
| Device Name: | NEO-CARE LUMBER PUNCTURE KIT |
| Classification | Needle, Spinal, Short Term |
| Applicant | KLEIN-BAKER MEDICAL, INC. 12001 NETWORK, SUITE 110 San Antonio, TX 78249 |
| Contact | Clyde N Baker |
| Correspondent | Clyde N Baker KLEIN-BAKER MEDICAL, INC. 12001 NETWORK, SUITE 110 San Antonio, TX 78249 |
| Product Code | MIA |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-19 |
| Decision Date | 1997-05-22 |