The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Safe-t-peel Safety Needle/introducer, Models 350-300 S, 360-300's,380-300's,390-300's.
| Device ID | K022099 |
| 510k Number | K022099 |
| Device Name: | SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | HDC CORP. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan HDC CORP. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-27 |
| Decision Date | 2002-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3393903005 | K022099 | 000 |
| B3393803005 | K022099 | 000 |
| B3393603005 | K022099 | 000 |
| B3393503005 | K022099 | 000 |
| B33920763000 | K022099 | 000 |