The following data is part of a premarket notification filed by Save-t-breath Distributors C.c. with the FDA for Save-t-breath Ambilical Cord Clamp.
| Device ID | K933763 |
| 510k Number | K933763 |
| Device Name: | SAVE-T-BREATH AMBILICAL CORD CLAMP |
| Classification | Clamp, Umbilical |
| Applicant | SAVE-T-BREATH DISTRIBUTORS C.C. P.O.BOX 87523 HOUGHTON 2041 South Africa, ZA |
| Contact | C. Nates |
| Correspondent | C. Nates SAVE-T-BREATH DISTRIBUTORS C.C. P.O.BOX 87523 HOUGHTON 2041 South Africa, ZA |
| Product Code | HFW |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-03 |
| Decision Date | 1994-08-29 |