The following data is part of a premarket notification filed by Global Medical Prods, Inc. with the FDA for Global Medical Products Spinal,conical Tip (sprottle Style), Whitacre Style Needles.
| Device ID | K961324 |
| 510k Number | K961324 |
| Device Name: | GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES |
| Classification | Needle, Spinal, Short Term |
| Applicant | GLOBAL MEDICAL PRODS, INC. NO STREET ADDRESS Oakville Ont.l6l 5k9, CA |
| Contact | Peter Clark |
| Correspondent | Peter Clark GLOBAL MEDICAL PRODS, INC. NO STREET ADDRESS Oakville Ont.l6l 5k9, CA |
| Product Code | MIA |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-08 |
| Decision Date | 1996-07-02 |